ID

26079

Beschreibung

Study ID: 100601 Clinical Study ID: LPL100601 Study Title: LPL100601, A Clinical Outcomes Study of Darapladib versus Placebo in Subjects with Chronic Coronary Heart Disease to Compare the Incidence of Major Adverse Cardiovascular Events (MACE) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00799903 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: darapladib Trade Name: darapladib Study Indication: Atherosclerosis Study part: Endpoint revascularisation - Repeating form (Scheduled visits)

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GlaxoSmithKline

Hochgeladen am

7. Oktober 2017

DOI

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Endpoint revascularisation GSK study Chronic Coronary Heart Disease NCT00799903

Englisch

Endpoint revascularisation GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulare  
Coronary revascularisation
Beschreibung

Coronary revascularisation

1. Date of procedure
Beschreibung

Date of procedure

Datentyp

date

1. Start time of procedure
Beschreibung

Start time of procedure

Datentyp

time

2. Revascularisation procedure
Beschreibung

Revascularisation procedure

Datentyp

text

If PCI - single vessel, select one
Beschreibung

PCI single vessel

Datentyp

text

If PCI - single vessel with stent: C02 Bare metal
Beschreibung

PCI single vessel with stent Bare metal

Datentyp

boolean

If PCI - single vessel with stent (bare metal), indicate number of stents
Beschreibung

number of stents bare metal single vessel

Datentyp

integer

If PCI - single vessel with stent: C03 Drug-eluting
Beschreibung

PCI single vessel with stent Drug-eluting

Datentyp

boolean

If PCI - single vessel with stent (drug-eluting), indicate number of stents
Beschreibung

number of stents drug-eluting single vessel

Datentyp

integer

If PCI - multiple vessels, select one
Beschreibung

PCI multiple vessels

Datentyp

text

If PCI - multiple vessels with stent: C05 Bare metal
Beschreibung

PCI multiple vessels with stent Bare metal

Datentyp

boolean

If PCI - multiple vessels with stent (bare metal), indicate number of stents
Beschreibung

number of stents bare metal multiple vessels

Datentyp

integer

If PCI - multiple vessels with stent: C06 Drug-eluting
Beschreibung

PCI multiple vessels with stent Drug-eluting

Datentyp

boolean

If PCI - multiple vessels with stent (drug-eluting), indicate number of stents
Beschreibung

number of stents drug-eluting multiple vessels

Datentyp

integer

If CABG: C07 Arterial graft
Beschreibung

CABG Arterial graft

Datentyp

boolean

Number of grafts
Beschreibung

CABG arterial graft number

Datentyp

integer

If CABG: C08 Saphenous vein graft
Beschreibung

CABG Saphenous vein graft

Datentyp

boolean

Number of grafts
Beschreibung

CABG Saphenous vein graft number

Datentyp

integer

3. Was this a revascularisation of a target lesion from PCI that was performed prior to randomization?
Beschreibung

revascularisation of a target lesion from PCI

Datentyp

text

4. Did subject have ischemic discomfort at rest?
Beschreibung

ischemic discomfort at rest

Datentyp

boolean

Did ischemic disomfort at rest prompt coronary revascularisation (PCI or CABG) during the same hospitalisation?
Beschreibung

ischemic disomfort prompting coronary revascularisation

Datentyp

boolean

Did ischemic discomfort at rest result in hospital transfer for the purpose of coronary revascularisation?
Beschreibung

ischemic discomfort resulting in hospital transfer

Datentyp

boolean

Was ischemic discomfort at rest > 10 minutes?
Beschreibung

ischemic discomfort less than 10 minutes

Datentyp

text

5. Other interventions: [6] ECG
Beschreibung

Select all that apply. Complete the ECG evidence of myocardial ischemia/infarction form for ALL ECGs related to this event.

Datentyp

boolean

5. Other interventions: [7] Cardiac biomarkers
Beschreibung

Select all that apply. Complete the Cardiac Biomarkers form

Datentyp

boolean

6. Provide narrative
Beschreibung

narrative

Datentyp

text

7. Date documents sent to CEC Document Group
Beschreibung

Date documents sent to CEC Document Group

Datentyp

date

Urgent coronary revascularisation for myocardial ischemia
Beschreibung

Urgent coronary revascularisation for myocardial ischemia

6. Adjudication
Beschreibung

[hidden]

Datentyp

text

If criteria for urgent coronary revscularisation for myocardial ischemia not met, comment
Beschreibung

criteria for urgent coronary revscularisation for myocardial ischemia not met

Datentyp

text

Criteria for urgent coronary revscularisation for myocardial ischemia not met: [71] Non-urgent coronary revascularisation
Beschreibung

Non-urgent coronary revascularisation

Datentyp

boolean

Criteria for urgent coronary revscularisation for myocardial ischemia not met: [99] Revascularisation was a treatment for MI
Beschreibung

Revascularisation was a treatment for MI

Datentyp

boolean

9. Was this event related to a stent thrombosis?
Beschreibung

[hidden]

Datentyp

text

10. Additional Findings: 1. Adjudication
Beschreibung

As a result of the revascularization, criterion for a peri-procedural MI was met. MI adjudication for event not already reported by investigaton [hidden]

Datentyp

integer

10. Additional Findings: 2. Classification of MI
Beschreibung

As a result of the revascularization, criterion for a peri-procedural MI was met. MI adjudication for event not already reported by investigaton [hidden]

Datentyp

integer

If acute, select one
Beschreibung

Acute MI

Datentyp

text

If prior MI (occurred after randomisation), select one
Beschreibung

prior MI

Datentyp

text

10. Additional Findings: 3. STEMI / NSTEMI
Beschreibung

As a result of the revascularization, criterion for a peri-procedural MI was met. MI adjudication for event not already reported by investigaton [hidden]

Datentyp

text

10. Additional Findings: 4. Q wave/Non-Q wave
Beschreibung

As a result of the revascularization, criterion for a peri-procedural MI was met. MI adjudication for event not already reported by investigaton [hidden]

Datentyp

text

10. Additional Findings: 5. Type of MI
Beschreibung

As a result of the revascularization, criterion for a peri-procedural MI was met. MI adjudication for event not already reported by investigaton [hidden]

Datentyp

text

11. Date of adjudication
Beschreibung

[hidden]

Datentyp

date

CEC Status
Beschreibung

CEC Status

12. Trigger number
Beschreibung

[hidden]

Datentyp

text

13. CEC Status
Beschreibung

[read-only]

Datentyp

integer

14. Date of status change
Beschreibung

[read-only]

Datentyp

date

15. Physician review #1: Physician
Beschreibung

[hidden]

Datentyp

integer

15. Physician review #1: Date sent to reviewer
Beschreibung

[hidden]

Datentyp

date

15. Physician review #1: Date received from reviewer
Beschreibung

[hidden]

Datentyp

date

16. Physician review #2: Physician
Beschreibung

[hidden]

Datentyp

integer

16. Physician review #2: Date sent to reviewer
Beschreibung

[hidden]

Datentyp

date

16. Physician review #2: Date received from reviewer
Beschreibung

[hidden]

Datentyp

date

17. CEC Coordinator comments
Beschreibung

[hidden]

Datentyp

text

18. CV event number
Beschreibung

[hidden]

Datentyp

text

19. Adverse event reference identifier
Beschreibung

Use SAE Sequence number from the corresponding SAE form (the last item on the form, in the "Non-Clinical" section) [hidden].

Datentyp

text

20. Adverse event term
Beschreibung

Copy Serious Adverse Event term from corresponding SAE form [hidden].

Datentyp

text

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Ähnliche Modelle

Endpoint revascularisation GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Coronary revascularisation
Date of procedure
Item
1. Date of procedure
date
Start time of procedure
Item
1. Start time of procedure
time
Item
2. Revascularisation procedure
text
Revascularisation procedure
Code List
2. Revascularisation procedure
CL Item
PCI - single vessel (CA)
CL Item
PCI - multiple vessels (CC)
CL Item
CABG (CE)
CL Item
Revascularisation procedure attempted but not successful (C09)
Item
If PCI - single vessel, select one
text
PCI single vessel
Code List
If PCI - single vessel, select one
CL Item
without stent (C01)
CL Item
with stent (CB)
PCI single vessel with stent Bare metal
Item
If PCI - single vessel with stent: C02 Bare metal
boolean
number of stents bare metal single vessel
Item
If PCI - single vessel with stent (bare metal), indicate number of stents
integer
PCI single vessel with stent Drug-eluting
Item
If PCI - single vessel with stent: C03 Drug-eluting
boolean
number of stents drug-eluting single vessel
Item
If PCI - single vessel with stent (drug-eluting), indicate number of stents
integer
Item
If PCI - multiple vessels, select one
text
PCI single vessel
Code List
If PCI - multiple vessels, select one
CL Item
without stent (C04)
CL Item
with stent (CD)
PCI multiple vessels with stent Bare metal
Item
If PCI - multiple vessels with stent: C05 Bare metal
boolean
number of stents bare metal multiple vessels
Item
If PCI - multiple vessels with stent (bare metal), indicate number of stents
integer
PCI multiple vessels with stent Drug-eluting
Item
If PCI - multiple vessels with stent: C06 Drug-eluting
boolean
number of stents drug-eluting multiple vessels
Item
If PCI - multiple vessels with stent (drug-eluting), indicate number of stents
integer
CABG Arterial graft
Item
If CABG: C07 Arterial graft
boolean
CABG arterial graft number
Item
Number of grafts
integer
CABG Saphenous vein graft
Item
If CABG: C08 Saphenous vein graft
boolean
CABG Saphenous vein graft number
Item
Number of grafts
integer
Item
3. Was this a revascularisation of a target lesion from PCI that was performed prior to randomization?
text
revascularisation of a target lesion from PCI
Code List
3. Was this a revascularisation of a target lesion from PCI that was performed prior to randomization?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
ischemic discomfort at rest
Item
4. Did subject have ischemic discomfort at rest?
boolean
ischemic disomfort prompting coronary revascularisation
Item
Did ischemic disomfort at rest prompt coronary revascularisation (PCI or CABG) during the same hospitalisation?
boolean
ischemic discomfort resulting in hospital transfer
Item
Did ischemic discomfort at rest result in hospital transfer for the purpose of coronary revascularisation?
boolean
ischemic discomfort less than 10 minutes
Item
Was ischemic discomfort at rest > 10 minutes?
text
Other interventions ECG
Item
5. Other interventions: [6] ECG
boolean
Other interventions ECG
Item
5. Other interventions: [7] Cardiac biomarkers
boolean
narrative
Item
6. Provide narrative
text
Date documents sent to CEC Document Group
Item
7. Date documents sent to CEC Document Group
date
Item Group
Urgent coronary revascularisation for myocardial ischemia
Item
6. Adjudication
text
Adjudication
Code List
6. Adjudication
CL Item
Urgent coronary revascularisation for myocardial ischemia (70)
CL Item
Does not meet criteria for urgent coronary revscularisation for myocardial ischemia (NC)
criteria for urgent coronary revscularisation for myocardial ischemia not met
Item
If criteria for urgent coronary revscularisation for myocardial ischemia not met, comment
text
Non-urgent coronary revascularisation
Item
Criteria for urgent coronary revscularisation for myocardial ischemia not met: [71] Non-urgent coronary revascularisation
boolean
Revascularisation was a treatment for MI
Item
Criteria for urgent coronary revscularisation for myocardial ischemia not met: [99] Revascularisation was a treatment for MI
boolean
Item
9. Was this event related to a stent thrombosis?
text
Was this event related to a stent thrombosis?
Code List
9. Was this event related to a stent thrombosis?
CL Item
Definite (DF)
CL Item
Probable (PB)
CL Item
No (N)
CL Item
Unknown (U)
Item
10. Additional Findings: 1. Adjudication
integer
Additional Findings
Code List
10. Additional Findings: 1. Adjudication
CL Item
Fatal MI (34)
CL Item
Non-fatal MI (35)
Item
10. Additional Findings: 2. Classification of MI
integer
Additional Findings
Code List
10. Additional Findings: 2. Classification of MI
CL Item
Acute (38)
CL Item
Prior MI (occurred after randomisation) (39)
Item
If acute, select one
text
Acute MI
Code List
If acute, select one
CL Item
No recent revascularisation, baseline biomarkers not elevated - Rise/fall biomarkers >99th %ile URL (A25)
CL Item
No recent revascularisation, post-MI baseline biomarkers elevated - biomarker decreasing prior to new suspect MI then re-elevation >50% of (A26)
CL Item
previous value (previous value)
CL Item
Sudden unexpected cardiac death involving cardiac arrest, often with symptoms of myocardial ischemia, accompanied by new ST (A08)
CL Item
elevation/LBBB, fresh thrombus by coronary angiography/autopsy, but dying before blood obtained, or appearance of cardiac biomarkers (elevation/LBBB, fresh thrombus by coronary angiography/autopsy, but dying before blood obtained, or appearance of cardiac biomarkers)
CL Item
Within 24 hours post-PCI, either 1) rise of CK-MB; OR 2) pathological findings of acute MI. Subtype is related to stent thrombosis (A27)
CL Item
Annotated Trial Design Page 206 of 307 (Annotated Trial Design Page 206 of 307)
CL Item
Within 72 hours post-CABG, either 1) rise of CK-MB + at least 1 additional criteria; OR 2) pathological findings of acute MI. (A28)
CL Item
Pathological findings of acute myocardial infarction at post mortem (A09)
Item
If prior MI (occurred after randomisation), select one
text
prior MI
Code List
If prior MI (occurred after randomisation), select one
CL Item
Development of new pathological Q waves with or without symptoms (A13)
CL Item
Imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (A07)
CL Item
Pathological findings of a healed or healing myocardial infarction (A14)
Item
10. Additional Findings: 3. STEMI / NSTEMI
text
Additional Findings
Code List
10. Additional Findings: 3. STEMI / NSTEMI
CL Item
STEMI (20)
CL Item
NSTEMI (21)
CL Item
Not applicable (X)
Item
10. Additional Findings: 4. Q wave/Non-Q wave
text
Additional Findings
Code List
10. Additional Findings: 4. Q wave/Non-Q wave
CL Item
Q wave (A15)
CL Item
Non-Q wave (A16)
CL Item
Q wave undetermined - no ECG available (A24)
Item
10. Additional Findings: 5. Type of MI
text
Additional Findings
Code List
10. Additional Findings: 5. Type of MI
CL Item
Type 1: Spontaneous myocardial infarction related to ischemia due to a primary coronary event such as plaque erosion and/or rupture, fissuring, or (A17)
CL Item
dissection (dissection)
CL Item
Type 2: Myocardial infarction secondary to ischemia due to either increased oxygen demand or decreased supply, e.g. coronary artery spasm, coronary (A18)
CL Item
embolism, anemia, arrhythmias, hypertension, or hypotension (embolism, anemia, arrhythmias, hypertension, or hypotension)
CL Item
Type 3: Sudden unexpected cardiac death often with symptoms of myocardial ischemia, accompanied by new ST elevation or new LBBB, or fresh (A19)
CL Item
thrombus in a coronary artery, but dying before blood samples obtained or before the appearance of cardiac biomarkers (thrombus in a coronary artery, but dying before blood samples obtained or before the appearance of cardiac biomarkers)
CL Item
Type 4a: Myocardial infarction associated with PCI (A20)
CL Item
Type 4b: Myocardial infarction associated with stent thrombosis as documented by angiography or at autopsy (A21)
CL Item
Type 5: Myocardial infarction associated with CABG (A22)
Date of adjudication
Item
11. Date of adjudication
date
Item Group
CEC Status
Trigger number
Item
12. Trigger number
text
Item
13. CEC Status
integer
CEC Status
Code List
13. CEC Status
CL Item
New (1)
CL Item
Coordinator Screen check (2)
CL Item
Hold (3)
CL Item
Ready for review (4)
CL Item
In Phase I review (5)
CL Item
Queried (InForm) (6)
CL Item
Additional documents required (7)
CL Item
In Phase II committee (8)
CL Item
Data change (9)
CL Item
Re-Review (10)
CL Item
Completed event (11)
CL Item
No event to adjudicate (12)
CL Item
QC Random sample (13)
CL Item
In Translation (14)
Date of status change
Item
14. Date of status change
date
Item
15. Physician review #1: Physician
integer
Physician review 1 Physician
Code List
15. Physician review #1: Physician
CL Item
01 (1)
CL Item
02 (2)
CL Item
03 (3)
CL Item
04 (4)
CL Item
05 (5)
CL Item
06 (6)
CL Item
07 (7)
CL Item
08 (8)
CL Item
09 (9)
CL Item
10 (10)
CL Item
11 (11)
CL Item
12 (12)
CL Item
13 (13)
CL Item
4 (14)
CL Item
15 (15)
CL Item
16 (16)
CL Item
17 (17)
CL Item
18 (18)
CL Item
19 (19)
CL Item
20 (20)
CL Item
21 (21)
CL Item
22 (22)
CL Item
23 (23)
CL Item
24 (24)
CL Item
25 (25)
CL Item
26 (26)
CL Item
27 (27)
CL Item
28 (28)
CL Item
29 (29)
CL Item
30 (30)
CL Item
31 (31)
CL Item
32 (32)
CL Item
33 (33)
CL Item
34 (34)
CL Item
35 (35)
CL Item
36 (36)
CL Item
37 (37)
CL Item
38 (38)
CL Item
39 (39)
CL Item
40 (40)
CL Item
41 (41)
CL Item
42 (42)
CL Item
43 (43)
CL Item
4 (44)
CL Item
45 (45)
CL Item
46 (46)
CL Item
47 (47)
CL Item
48 (48)
CL Item
49 (49)
CL Item
50 (50)
Physician review 1 Date sent to reviewer
Item
15. Physician review #1: Date sent to reviewer
date
Physician review 1 Date received from reviewer
Item
15. Physician review #1: Date received from reviewer
date
Item
16. Physician review #2: Physician
integer
Physician review 1 Physician
Code List
16. Physician review #2: Physician
CL Item
01 (1)
CL Item
02 (2)
CL Item
03 (3)
CL Item
04 (4)
CL Item
05 (5)
CL Item
06 (6)
CL Item
07 (7)
CL Item
08 (8)
CL Item
09 (9)
CL Item
10 (10)
CL Item
11 (11)
CL Item
12 (12)
CL Item
13 (13)
CL Item
4 (14)
CL Item
15 (15)
CL Item
16 (16)
CL Item
17 (17)
CL Item
18 (18)
CL Item
19 (19)
CL Item
20 (20)
CL Item
21 (21)
CL Item
22 (22)
CL Item
23 (23)
CL Item
24 (24)
CL Item
25 (25)
CL Item
26 (26)
CL Item
27 (27)
CL Item
28 (28)
CL Item
29 (29)
CL Item
30 (30)
CL Item
31 (31)
CL Item
32 (32)
CL Item
33 (33)
CL Item
34 (34)
CL Item
35 (35)
CL Item
36 (36)
CL Item
37 (37)
CL Item
38 (38)
CL Item
39 (39)
CL Item
40 (40)
CL Item
41 (41)
CL Item
42 (42)
CL Item
43 (43)
CL Item
4 (44)
CL Item
45 (45)
CL Item
46 (46)
CL Item
47 (47)
CL Item
48 (48)
CL Item
49 (49)
CL Item
50 (50)
Physician review 2 Date sent to reviewer
Item
16. Physician review #2: Date sent to reviewer
date
Physician review 2 Date received from reviewer
Item
16. Physician review #2: Date received from reviewer
date
CEC Coordinator comments
Item
17. CEC Coordinator comments
text
CV event number
Item
18. CV event number
text
Adverse event reference identifier
Item
19. Adverse event reference identifier
text
Adverse event term
Item
20. Adverse event term
text
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