ID

26080

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 Hospitalisation for unstable angina - Repeating form (Scheduled visits)

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Rechteinhaber

GlaxoSmithKline

Hochgeladen am

7. Oktober 2017

DOI

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Creative Commons BY-NC 3.0
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Endpoint Hospitalisation for unstable angina GSK study Chronic Coronary Heart Disease NCT00799903

Englisch

Endpoint Hospitalisation for unstable angina GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulare  
Investigator section
Beschreibung

Investigator section

1. Date of hospital admission
Beschreibung

Date of hospital admission

Datentyp

date

2. At time of admission, was subject hospitalised for unstable angina (and did not fulfill criteria for MI)?
Beschreibung

Hospitalisation unstable angina at time of admission

Datentyp

boolean

2. If yes, select one
Beschreibung

Ischemic discomfort at rest

Datentyp

text

2. If yes, was ischemic discomfort at rest > 10 minutes?
Beschreibung

ischemic discomfort at rest duration

Datentyp

boolean

3. In-hospital treatments and interventions: [D05] Parenteral anti-coagulant treatment
Beschreibung

Select all that apply

Datentyp

boolean

3. In-hospital treatments and interventions: [D06] Parenteral anti-platelet treatment
Beschreibung

Select all that apply

Datentyp

boolean

3. In-hospital treatments and interventions: [D07] Coronary revascularisation
Beschreibung

Select all that apply. Complete Endpoint form

Datentyp

boolean

3. If coronary revascularisation: [D08] PCI
Beschreibung

Select all that apply

Datentyp

boolean

3. If coronary revascularisation: [D09] CABG
Beschreibung

Select all that apply

Datentyp

boolean

3. In-hospital treatments and interventions: [6] ECG
Beschreibung

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

Datentyp

boolean

3. In-hospital treatments and interventions: [7] Cardiac biomarkers
Beschreibung

Select all that apply. Complete Endpoint form. Complete the Cardiac Biomarkers form.

Datentyp

boolean

3. In-hospital treatments and interventions: [OT] Other cardiac procedure
Beschreibung

Select all that apply. Complete Endpoint form.

Datentyp

boolean

4. Provide narrative
Beschreibung

narrative

Datentyp

text

CEC Section
Beschreibung

CEC Section

6. Adjudication
Beschreibung

[hidden]

Datentyp

text

6. If yes, select one
Beschreibung

Adjudication Ischemic discomfort at rest

Datentyp

text

6. Was ischemic discomfort at rest > 10 minutes?
Beschreibung

adjudication ischemic discomfort at rest duration

Datentyp

boolean

6. If criteria for unstable angina are not met, specify
Beschreibung

criteria for unstable angina not met specification

Datentyp

text

6. If criteria for unstable angina are not met: [41] Meets criteria for MI
Beschreibung

criteria for MI met

Datentyp

boolean

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

[hidden]

Datentyp

text

8. MI adjudication: 1. Adjudication
Beschreibung

Only to be completed for events adjudicated to be an MI [hidden]

Datentyp

integer

8. MI adjudication: 2. Classification of MI
Beschreibung

Only to be completed for events adjudicated to be an MI [hidden]

Datentyp

integer

If acute MI, select one
Beschreibung

MI adjudication acute

Datentyp

text

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

MI adjudication prior

Datentyp

text

8. MI adjudication: 3. STEMI / NSTEMI
Beschreibung

Only to be completed for events adjudicated to be an MI [hidden]

Datentyp

text

8. MI adjudication: 4. Q wave/Non-Q wave
Beschreibung

Only to be completed for events adjudicated to be an MI [hidden]

Datentyp

text

8. MI adjudication: 5. Type of MI
Beschreibung

Only to be completed for events adjudicated to be an MI [hidden]

Datentyp

text

9. Date of adjudication
Beschreibung

[hidden]

Datentyp

date

CEC Status
Beschreibung

CEC Status

10. Trigger number
Beschreibung

[hidden]

Datentyp

text

11. CEC Status
Beschreibung

[read-only]

Datentyp

integer

12. Date of status change
Beschreibung

[read-only]

Datentyp

date

13. Physician review #1: Physician
Beschreibung

[hidden]

Datentyp

integer

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

[hidden]

Datentyp

date

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

[hidden]

Datentyp

date

14. Physician review #2: Physician
Beschreibung

[hidden]

Datentyp

integer

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

[hidden]

Datentyp

date

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

[hidden]

Datentyp

date

15. CEC Coordinator comments
Beschreibung

[hidden]

Datentyp

text

16. CV event number
Beschreibung

[hidden]

Datentyp

text

17. 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

18. Adverse event term
Beschreibung

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

Datentyp

text

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Ähnliche Modelle

Endpoint Hospitalisation for unstable angina GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Investigator section
Date of hospital admission
Item
1. Date of hospital admission
date
Hospitalisation unstable angina at time of admission
Item
2. At time of admission, was subject hospitalised for unstable angina (and did not fulfill criteria for MI)?
boolean
Item
2. If yes, select one
text
Ischemic discomfort at rest
Code List
2. If yes, select one
CL Item
Ischemic discomfort at rest associated with ECG changes leading to hospitalisation (D01)
CL Item
Ischemic discomfort at rest regardless of ECG changes leading to hospitalisation AND revascularisation during the (D02)
CL Item
same admission (same admission)
CL Item
Ischemic discomfort at rest in hospital associated with ECG changes (D03)
CL Item
Ischemic discomfort at rest in hospital without ECG changes resulting in revascularisation during the same admission (D04)
ischemic discomfort at rest duration
Item
2. If yes, was ischemic discomfort at rest > 10 minutes?
boolean
Parenteral anti-coagulant treatment
Item
3. In-hospital treatments and interventions: [D05] Parenteral anti-coagulant treatment
boolean
Parenteral anti-platelet treatment
Item
3. In-hospital treatments and interventions: [D06] Parenteral anti-platelet treatment
boolean
Coronary revascularisation
Item
3. In-hospital treatments and interventions: [D07] Coronary revascularisation
boolean
PCI
Item
3. If coronary revascularisation: [D08] PCI
boolean
CABG
Item
3. If coronary revascularisation: [D09] CABG
boolean
ECG
Item
3. In-hospital treatments and interventions: [6] ECG
boolean
Cardiac biomarkers
Item
3. In-hospital treatments and interventions: [7] Cardiac biomarkers
boolean
Other cardiac procedure
Item
3. In-hospital treatments and interventions: [OT] Other cardiac procedure
boolean
narrative
Item
4. Provide narrative
text
Item Group
CEC Section
Item
6. Adjudication
text
Adjudication
Code List
6. Adjudication
CL Item
Yes (36)
CL Item
Does not meet criteria for unstable angina (NC)
Item
6. If yes, select one
text
Ischemic discomfort at rest
Code List
6. If yes, select one
CL Item
Ischemic discomfort at rest associated with ECG changes leading to hospitalisation (D01)
CL Item
Ischemic discomfort at rest regardless of ECG changes leading to hospitalisation AND revascularisation during the (D02)
CL Item
same admission (same admission)
CL Item
Ischemic discomfort at rest in hospital associated with ECG changes (D03)
CL Item
Ischemic discomfort at rest in hospital without ECG changes resulting in revascularisation during the same admission (D04)
adjudication ischemic discomfort at rest duration
Item
6. Was ischemic discomfort at rest > 10 minutes?
boolean
criteria for unstable angina not met specification
Item
6. If criteria for unstable angina are not met, specify
text
criteria for MI met
Item
6. If criteria for unstable angina are not met: [41] Meets criteria for MI
boolean
Item
7. Was this event related to a stent thrombosis?
text
event related to stent thrombosis
Code List
7. 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
8. MI adjudication: 1. Adjudication
integer
MI adjudication
Code List
8. MI adjudication: 1. Adjudication
CL Item
Fatal MI (34)
CL Item
Non-fatal MI (35)
Item
8. MI adjudication: 2. Classification of MI
integer
MI adjudication
Code List
8. MI adjudication: 2. Classification of MI
CL Item
Acute (38)
CL Item
Prior MI (occurred after randomisation) (39)
Item
If acute MI, select one
text
MI adjudication acute
Code List
If acute MI, 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 (A26)
CL Item
then re-elevation >50% of previous value (then re-elevation >50% of previous value)
CL Item
Sudden unexpected cardiac death involving cardiac arrest, often with symptoms of myocardial ischemia, (A08)
CL Item
accompanied by new ST elevation/LBBB, fresh thrombus by coronary angiography/autopsy, but dying before blood (accompanied by new ST elevation/LBBB, fresh thrombus by coronary angiography/autopsy, but dying before blood)
CL Item
obtained, or appearance of cardiac biomarkers (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 (A27)
CL Item
stent thrombosis (stent thrombosis)
CL Item
Within 72 hours post-CABG, either 1) rise of CK-MB + at least 1 additional criteria; OR 2) pathological findings of (A28)
CL Item
acute MI. (acute MI.)
CL Item
Pathological findings of acute myocardial infarction at post mortem (A09)
Item
If prior MI (occurred after randomisation), select one
text
MI adjudication acute
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 (A07)
CL Item
non-ischemic cause (non-ischemic cause)
CL Item
Pathological findings of a healed or healing myocardial infarction (A14)
Item
8. MI adjudication: 3. STEMI / NSTEMI
text
MI adjudication
Code List
8. MI adjudication: 3. STEMI / NSTEMI
CL Item
STEMI (20)
CL Item
NSTEMI (21)
CL Item
Not applicable (X)
Item
8. MI adjudication: 4. Q wave/Non-Q wave
text
MI adjudication
Code List
8. MI adjudication: 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
8. MI adjudication: 5. Type of MI
text
MI adjudication
Code List
8. MI adjudication: 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 (A17)
CL Item
rupture, fissuring, or dissection (rupture, fissuring, or dissection)
CL Item
Type 2: Myocardial infarction secondary to ischemia due to either increased oxygen demand or decreased supply, e.g. (A18)
CL Item
coronary artery spasm, coronary embolism, anemia, arrhythmias, hypertension, or hypotension (coronary artery spasm, coronary 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 (A19)
CL Item
new LBBB, or fresh thrombus in a coronary artery, but dying before blood samples obtained or before the appearance of (new LBBB, or fresh thrombus in a coronary artery, but dying before blood samples obtained or before the appearance of)
CL Item
cardiac biomarkers (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
9. Date of adjudication
date
Item Group
CEC Status
Trigger number
Item
10. Trigger number
text
Item
11. CEC Status
integer
CEC Status
Code List
11. 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
12. Date of status change
date
Item
13. Physician review #1: Physician
integer
Physician review 1 Physician
Code List
13. 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
13. Physician review #1: Date sent to reviewer
date
Physician review 1 Date received from reviewer
Item
13. Physician review #1: Date received from reviewer
date
Item
14. Physician review #2: Physician
integer
Physician review 1 Physician
Code List
14. 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
14. Physician review #2: Date sent to reviewer
date
Physician review 2 Date received from reviewer
Item
14. Physician review #2: Date received from reviewer
date
CEC Coordinator comments
Item
15. CEC Coordinator comments
text
CV event number
Item
16. CV event number
text
Adverse event reference identifier
Item
17. Adverse event reference identifier
text
Adverse event term
Item
18. Adverse event term
text
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