ID

26333

Beschrijving

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 Myocardial infarction - Repeating form (Scheduled visits)

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Versies (6)
  1. 05-10-17 05-10-17 -
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  3. 10-10-17 10-10-17 -
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  5. 23-10-17 23-10-17 -
  6. 03-01-18 03-01-18 -
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GlaxoSmithKline

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16 oktober 2017

DOI

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Creative Commons BY-NC 3.0
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Endpoint Myocardial infarction GSK study Chronic Coronary Heart Disease NCT00799903

Engels

Endpoint Myocardial infarction GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulieren  
Investigator Section
Beschrijving

Investigator Section

1. Date of onset of MI symptoms
Beschrijving

Date of onset of MI symptoms

Datatype

date

1. Time of onset of MI symptoms
Beschrijving

Time of onset of MI symptoms

Datatype

time

2. Date of MI diagnosis
Beschrijving

Date of MI diagnosis

Datatype

date

2. Time of MI diagnosis
Beschrijving

Time of MI diagnosis

Datatype

time

3. Event details: Cardiac biomarkers - peak value supporting diagnosis (specify test and result)
Beschrijving

Select all that apply. Complete the Cardiac Biomarkers form

Datatype

boolean

3. Event details: [A2] ECG changes
Beschrijving

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

Datatype

boolean

3. Event details: [A3] Symptoms of ischemia
Beschrijving

Select all that apply.

Datatype

boolean

3. Event details: [A4] Associated with PCI without stent thrombosis
Beschrijving

Select all that apply.

Datatype

boolean

3. Event details: [A5] Associated with PCI and stent thrombosis confirmed by angiography or autopsy
Beschrijving

Select all that apply.

Datatype

boolean

3. Event details: [A6] Associated with CABG
Beschrijving

Select all that apply.

Datatype

boolean

3. Event details: [A7] Imaging evidence
Beschrijving

Select all that apply. Complete the Cardiovascular Diagnostic Procedures form in the LOG visit

Datatype

boolean

3. Event details: [A8] Sudden, unexpected death, including cardiac arrest
Beschrijving

Select all that apply.

Datatype

boolean

3. Event details: [A9] Pathological findings of acute myocardial infarction at autopsy
Beschrijving

Select all that apply.

Datatype

boolean

4. Treatments and interventions: [1] Thrombolytic treatment
Beschrijving

Select all that apply

Datatype

boolean

4. Treatments and interventions: [2] Parenteral anti-coagulant treatment
Beschrijving

Select all that apply

Datatype

boolean

4. Treatments and interventions: [3] Parenteral anti-platelet treatment
Beschrijving

Select all that apply

Datatype

boolean

4. Treatments and interventions: [4] Coronary revascularisation
Beschrijving

Select all that apply. Complete endpoint form if appropriate

Datatype

boolean

4. Treatments and interventions: [4] If Coronary revascularisation, select one
Beschrijving

Select all that apply.

Datatype

integer

4. Treatments and interventions: [5] Other cardiac procedure (e.g., intra-aortic balloon, left ventricular assist device, pacemaker)
Beschrijving

Select all that apply.

Datatype

boolean

5. Outcome
Beschrijving

If fatal, complete the Endpoint - Death form

Datatype

integer

6. Provide narrative
Beschrijving

narrative

Datatype

text

7. Date documents sent to CEC Document Group
Beschrijving

Date documents sent to CEC Document Group

Datatype

date

CEC Section
Beschrijving

CEC Section

8. Adjudication
Beschrijving

[hidden]

Datatype

text

If criteria for myocardial infarction not met, comment
Beschrijving

criteria myocardial infarction comment

Datatype

text

[36] Meets criteria for secondary endpoint: Hospitalisation for unstable angina
Beschrijving

Hospitalisation for unstable angina

Datatype

boolean

9. Classification of MI
Beschrijving

[hidden]

Datatype

integer

If acute, select one
Beschrijving

Acute myocardial infarction

Datatype

text

If myocardial infarction diagnosed post-randomisation, select one
Beschrijving

myocardial infarction diagnosed post-randomisation

Datatype

text

10. STEMI / NSTEMI
Beschrijving

[hidden]

Datatype

text

11. Q wave/Non-Q wave
Beschrijving

[hidden]

Datatype

text

12. Type of MI
Beschrijving

[hidden]

Datatype

text

13. Was this event related to a stent thrombosis?
Beschrijving

[hidden]

Datatype

text

14. Unstable angina adjudication: 1. Adjudication
Beschrijving

Only to be completed for events adjudicated to be a hospitalisation for unstable angina [hidden]

Datatype

text

14. Unstable angina adjudication: 2. Was ischemic discomfort at rest > 10 minutes?
Beschrijving

Only to be completed for events adjudicated to be a hospitalisation for unstable angina [hidden]

Datatype

boolean

15. Date of adjudication
Beschrijving

[hidden]

Datatype

date

CEC STATUS
Beschrijving

CEC STATUS

16. Trigger number
Beschrijving

[hidden]

Datatype

text

17. CEC Status
Beschrijving

[read-only]

Datatype

integer

18. Date of status change
Beschrijving

[read-only]

Datatype

date

19. Physician review #1: Physician
Beschrijving

[hidden]

Datatype

integer

19. Physician review #1: Date sent to reviewer
Beschrijving

[hidden]

Datatype

date

19. Physician review #1: Date received from reviewer
Beschrijving

[hidden]

Datatype

date

19. Physician review #2: Physician
Beschrijving

[hidden]

Datatype

integer

19. Physician review #2: Date sent to reviewer
Beschrijving

[hidden]

Datatype

date

19. Physician review #2: Date received from reviewer
Beschrijving

[hidden]

Datatype

date

21. CEC Coordinator comments
Beschrijving

[hidden]

Datatype

text

22. CV event number
Beschrijving

[hidden]

Datatype

text

23. Adverse event reference identifier
Beschrijving

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

Datatype

text

24. Adverse event term
Beschrijving

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

Datatype

text

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Similar models

Endpoint Myocardial infarction GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Investigator Section
Date of onset of MI symptoms
Item
1. Date of onset of MI symptoms
date
Time of onset of MI symptoms
Item
1. Time of onset of MI symptoms
time
Date of MI diagnosis
Item
2. Date of MI diagnosis
date
Time of MI diagnosis
Item
2. Time of MI diagnosis
time
Event details Cardiac biomarkers
Item
3. Event details: Cardiac biomarkers - peak value supporting diagnosis (specify test and result)
boolean
Event details ECG changes
Item
3. Event details: [A2] ECG changes
boolean
Event details Symptoms of ischemia
Item
3. Event details: [A3] Symptoms of ischemia
boolean
Event details PCI without stent thrombosis
Item
3. Event details: [A4] Associated with PCI without stent thrombosis
boolean
Event details PCI and stent thrombosis
Item
3. Event details: [A5] Associated with PCI and stent thrombosis confirmed by angiography or autopsy
boolean
Event details Associated with CABG
Item
3. Event details: [A6] Associated with CABG
boolean
Event details Imaging evidence
Item
3. Event details: [A7] Imaging evidence
boolean
Event details Sudden death
Item
3. Event details: [A8] Sudden, unexpected death, including cardiac arrest
boolean
Event details acute myocardial infarction
Item
3. Event details: [A9] Pathological findings of acute myocardial infarction at autopsy
boolean
Treatments and interventions Thrombolytic treatment
Item
4. Treatments and interventions: [1] Thrombolytic treatment
boolean
Treatments and interventions Parenteral anti-coagulant treatment
Item
4. Treatments and interventions: [2] Parenteral anti-coagulant treatment
boolean
Treatments and interventions Parenteral anti-platelet treatment
Item
4. Treatments and interventions: [3] Parenteral anti-platelet treatment
boolean
Treatments and interventions Coronary revascularisation
Item
4. Treatments and interventions: [4] Coronary revascularisation
boolean
Item
4. Treatments and interventions: [4] If Coronary revascularisation, select one
integer
Treatments and interventions Coronary revascularisation specification
Code List
4. Treatments and interventions: [4] If Coronary revascularisation, select one
CL Item
PCI (1)
CL Item
CABG (2)
Treatments and interventions Other cardiac procedure
Item
4. Treatments and interventions: [5] Other cardiac procedure (e.g., intra-aortic balloon, left ventricular assist device, pacemaker)
boolean
Item
5. Outcome
integer
Outcome
Code List
5. Outcome
CL Item
Fatal  (34)
CL Item
Non-fatal (35)
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
CEC Section
Item
8. Adjudication
text
Adjudication
Code List
8. Adjudication
CL Item
Fatal MI (34)
CL Item
Non-fatal MI (35)
CL Item
Does not meet criteria for myocardial infarction (NC)
criteria myocardial infarction comment
Item
If criteria for myocardial infarction not met, comment
text
Hospitalisation for unstable angina
Item
[36] Meets criteria for secondary endpoint: Hospitalisation for unstable angina
boolean
Item
9. Classification of MI
integer
Classification of MI
Code List
9. Classification of MI
CL Item
Acute (38)
CL Item
Myocardial infarction diagnosed post-randomisation (80)
Item
If acute, select one
text
Acute myocardial infarction
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
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 myocardial infarction diagnosed post-randomisation, select one
text
myocardial infarction diagnosed post-randomisation
Code List
If myocardial infarction diagnosed post-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. STEMI / NSTEMI
text
STEMI / NSTEMI
Code List
10. STEMI / NSTEMI
CL Item
STEMI (20)
CL Item
NSTEMI (21)
CL Item
Not applicable (X)
Item
11. Q wave/Non-Q wave
text
Q wave/Non-Q wave
Code List
11. 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
12. Type of MI
text
Type of MI
Code List
12. 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 thrombus (A19)
CL Item
in a coronary artery, but dying before blood samples obtained or before the appearance of cardiac biomarkers (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)
Item
13. Was this event related to a stent thrombosis?
text
event related to stent thrombosis
Code List
13. 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
14. Unstable angina adjudication: 1. Adjudication
text
Unstable angina adjudication
Code List
14. Unstable angina adjudication: 1. Adjudication
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 same admission (D02)
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)
Unstable angina adjudication ischemic discomfort
Item
14. Unstable angina adjudication: 2. Was ischemic discomfort at rest > 10 minutes?
boolean
Date of adjudication
Item
15. Date of adjudication
date
Item Group
CEC STATUS
Trigger number
Item
16. Trigger number
text
Item
17. CEC Status
integer
CEC Status
Code List
17. 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
18. Date of status change
date
Item
19. Physician review #1: Physician
integer
Physician review 1
Code List
19. 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
14 (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
44 (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
19. Physician review #1: Date sent to reviewer
date
Physician review 1 Date received from reviewer
Item
19. Physician review #1: Date received from reviewer
date
Item
19. Physician review #2: Physician
integer
Physician review 1
Code List
19. 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
14 (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
44 (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
19. Physician review #2: Date sent to reviewer
date
Physician review 2 Date received from reviewer
Item
19. Physician review #2: Date received from reviewer
date
CEC Coordinator comments
Item
21. CEC Coordinator comments
text
CV event number
Item
22. CV event number
text
Adverse event reference identifier
Item
23. Adverse event reference identifier
text
Adverse event term
Item
24. Adverse event term
text
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