Trial Outcomes & Findings for EDUCATE: The MEDTRONIC Endeavor Drug Eluting Stenting: Understanding Care, Antiplatelet Agents and Thrombotic Events (NCT NCT01069003)
NCT ID: NCT01069003
Last Updated: 2016-01-20
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
2272 participants
Primary outcome timeframe
Placebo and Thienopyridine 12 - 30 months; Surveillance Arm (0 - 24 months)
Results posted on
2016-01-20
Participant Flow
Enrolled 2272 but only 2262 subjects were analysis receiving the Endeavor stent only.
Participant milestones
| Measure |
Placebo
Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of placebo thienopyridine and aspirin (ASA).
Placebo (12-Month Arm): Placebo
ASA: 75 mg - 325 mg Aspirin(ASA)
|
Thienopyridine Therapy
Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of active thienopyridine and aspirin (ASA).
Prasugrel and Clopidogrel (30-Month Arm): Prasugrel 5 or 10 mg; Clopidogrel 75 mg
ASA: 75 mg - 325 mg Aspirin(ASA)
|
Surveillance Arm
Non randomized subjects followed for total of 24 months
|
|---|---|---|---|
|
Overall Study
STARTED
|
399
|
412
|
1451
|
|
Overall Study
COMPLETED
|
353
|
358
|
976
|
|
Overall Study
NOT COMPLETED
|
46
|
54
|
475
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
EDUCATE: The MEDTRONIC Endeavor Drug Eluting Stenting: Understanding Care, Antiplatelet Agents and Thrombotic Events
Baseline characteristics by cohort
| Measure |
Placebo Arm
n=399 Participants
Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of placebo thienopyridine and aspirin (ASA).
Placebo (12-Month Arm): Placebo
ASA: 75 mg - 325 mg Aspirin(ASA)
|
Thienopyridine Therapy
n=412 Participants
Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of active thienopyridine and aspirin (ASA).
Prasugrel and Clopidogrel (30-Month Arm): Prasugrel 5 or 10 mg; Clopidogrel 75 mg
ASA: 75 mg - 325 mg Aspirin(ASA)
|
Surveillance Arm
n=1451 Participants
Non randomized subjects followed for total of 24 months
|
Total
n=2262 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
62.8 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
62.5 years
STANDARD_DEVIATION 10.7 • n=7 Participants
|
64.6 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
63.3 years
STANDARD_DEVIATION 10.9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
122 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
449 Participants
n=5 Participants
|
687 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
277 Participants
n=5 Participants
|
296 Participants
n=7 Participants
|
1002 Participants
n=5 Participants
|
1575 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
372 participants
n=5 Participants
|
385 participants
n=7 Participants
|
1409 participants
n=5 Participants
|
2166 participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
27 participants
n=5 Participants
|
27 participants
n=7 Participants
|
42 participants
n=5 Participants
|
96 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Placebo and Thienopyridine 12 - 30 months; Surveillance Arm (0 - 24 months)Outcome measures
| Measure |
Placebo Arm
n=392 Participants
Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of placebo thienopyridine and aspirin (ASA).
Placebo (12-Month Arm): Placebo
ASA: 75 mg - 325 mg Aspirin(ASA)
|
Thienopyridine Therapy
n=393 Participants
Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of active thienopyridine and aspirin (ASA).
Prasugrel and Clopidogrel (30-Month Arm): Prasugrel 5 or 10 mg; Clopidogrel 75 mg
ASA: 75 mg - 325 mg Aspirin(ASA)
|
Surveillance Arm
n=1451 Participants
Subjects followed for total of 24 months and not clear for randomization. Subjects who had a death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months prior to randomization.
|
|---|---|---|---|
|
Percentage of Participants With Composite of All Death, Target Vessel Myocardial Infarction (MI) and Stroke (Defined as MACCE) for Randomized Subjects
|
4.3 Percentage of participants
|
4.8 Percentage of participants
|
16.9 Percentage of participants
|
PRIMARY outcome
Timeframe: Placebo and Thienopyridine 12 - 30 months; Surveillance Arm (0 - 24 months)All definite and probable Stent Thrombosis (ST) are adjudicated by an independent committee according to the definition based on Academic Research Consortium (ARC) Definite is defined as angiographic or pathologic confirmation of partial or total thrombotic occlusion within the peri-stent region and at least 1 of the following: Acute ischemic symptoms, Ischemic ECG changes, Elevated cardiac biomarkers Probable defined as any unexplained death within the first 30 days of procedure and any myocardial infarction, which is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause
Outcome measures
| Measure |
Placebo Arm
n=392 Participants
Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of placebo thienopyridine and aspirin (ASA).
Placebo (12-Month Arm): Placebo
ASA: 75 mg - 325 mg Aspirin(ASA)
|
Thienopyridine Therapy
n=393 Participants
Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of active thienopyridine and aspirin (ASA).
Prasugrel and Clopidogrel (30-Month Arm): Prasugrel 5 or 10 mg; Clopidogrel 75 mg
ASA: 75 mg - 325 mg Aspirin(ASA)
|
Surveillance Arm
n=1451 Participants
Subjects followed for total of 24 months and not clear for randomization. Subjects who had a death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months prior to randomization.
|
|---|---|---|---|
|
Percentage of Participants of Incidence of ARC Definite or Probable Stent Thrombosis (ST) for Randomized Subjects
|
1.0 percentage of participants
|
0.5 percentage of participants
|
2.4 percentage of participants
|
PRIMARY outcome
Timeframe: Placebo and Thienopyridine 12 - 30 months; Surveillance Arm (0 - 24 months)Outcome measures
| Measure |
Placebo Arm
n=392 Participants
Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of placebo thienopyridine and aspirin (ASA).
Placebo (12-Month Arm): Placebo
ASA: 75 mg - 325 mg Aspirin(ASA)
|
Thienopyridine Therapy
n=393 Participants
Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of active thienopyridine and aspirin (ASA).
Prasugrel and Clopidogrel (30-Month Arm): Prasugrel 5 or 10 mg; Clopidogrel 75 mg
ASA: 75 mg - 325 mg Aspirin(ASA)
|
Surveillance Arm
n=1451 Participants
Subjects followed for total of 24 months and not clear for randomization. Subjects who had a death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months prior to randomization.
|
|---|---|---|---|
|
Incidence of Major Bleeding (GUSTO Classification, Severe and Moderate Bleeding Combined) for Randomized Subjects
|
1.8 Percentage of participants
|
2.0 Percentage of participants
|
4.8 Percentage of participants
|
Adverse Events
Placebo Arm
Serious events: 117 serious events
Other events: 0 other events
Deaths: 0 deaths
Thienopyridine Therapy
Serious events: 111 serious events
Other events: 0 other events
Deaths: 0 deaths
Surveillance Arm
Serious events: 664 serious events
Other events: 90 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo Arm
n=399 participants at risk
Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of placebo thienopyridine and aspirin (ASA).
Placebo (12-Month Arm): Placebo
ASA: 75 mg - 325 mg Aspirin(ASA)
|
Thienopyridine Therapy
n=412 participants at risk
Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of active thienopyridine and aspirin (ASA).
Prasugrel and Clopidogrel (30-Month Arm): Prasugrel 5 or 10 mg; Clopidogrel 75 mg
ASA: 75 mg - 325 mg Aspirin(ASA)
|
Surveillance Arm
n=1451 participants at risk
Non randomized subjects followed through 24 months
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
0.75%
3/399 • Number of events 3 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.24%
1/412 • Number of events 1 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
1.0%
15/1451 • Number of events 21 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
|
Cardiac disorders
Acute Myocardial Infarction
|
1.8%
7/399 • Number of events 7 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.73%
3/412 • Number of events 3 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
3.8%
55/1451 • Number of events 59 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
|
Blood and lymphatic system disorders
Anaemia
|
1.3%
5/399 • Number of events 6 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.49%
2/412 • Number of events 2 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
2.5%
37/1451 • Number of events 41 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
|
Cardiac disorders
Angina Pectoris
|
2.5%
10/399 • Number of events 10 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.73%
3/412 • Number of events 3 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
2.7%
39/1451 • Number of events 40 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
|
Cardiac disorders
Angina Unstable
|
0.25%
1/399 • Number of events 1 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.00%
0/412 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
2.1%
31/1451 • Number of events 32 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
|
Cardiac disorders
Atrial Fibrillation
|
1.5%
6/399 • Number of events 7 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.97%
4/412 • Number of events 4 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
1.7%
24/1451 • Number of events 26 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
|
Cardiac disorders
Atrial Flutter
|
0.00%
0/399 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.24%
1/412 • Number of events 1 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.14%
2/1451 • Number of events 2 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.50%
2/399 • Number of events 2 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.49%
2/412 • Number of events 4 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.62%
9/1451 • Number of events 10 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
|
Cardiac disorders
Bradycardia
|
0.25%
1/399 • Number of events 1 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.00%
0/412 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.96%
14/1451 • Number of events 14 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
|
Investigations
Cardiac Enzymes Increased
|
0.00%
0/399 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.24%
1/412 • Number of events 1 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
1.0%
15/1451 • Number of events 16 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.75%
3/399 • Number of events 7 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.73%
3/412 • Number of events 3 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
2.7%
39/1451 • Number of events 53 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
|
Cardiac disorders
Cardiogenic Shock
|
0.00%
0/399 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.24%
1/412 • Number of events 1 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.21%
3/1451 • Number of events 4 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
|
Nervous system disorders
Cerebrovascular Accident
|
1.0%
4/399 • Number of events 4 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.73%
3/412 • Number of events 3 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
1.3%
19/1451 • Number of events 22 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
|
General disorders
Chest Discomfort
|
0.50%
2/399 • Number of events 2 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.49%
2/412 • Number of events 2 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.41%
6/1451 • Number of events 6 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
|
General disorders
Chest Pain
|
2.8%
11/399 • Number of events 12 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
2.2%
9/412 • Number of events 10 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
6.7%
97/1451 • Number of events 128 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.75%
3/399 • Number of events 3 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.49%
2/412 • Number of events 2 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
1.4%
20/1451 • Number of events 33 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
|
Cardiac disorders
Coronary Artery Disease
|
3.3%
13/399 • Number of events 13 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
4.4%
18/412 • Number of events 20 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.00%
0/1451 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
|
Cardiac disorders
Coronary Artery Occlusion
|
0.00%
0/399 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.24%
1/412 • Number of events 1 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.00%
0/1451 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
|
Cardiac disorders
Coronary Artery Stenosis
|
0.25%
1/399 • Number of events 1 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.49%
2/412 • Number of events 2 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.00%
0/1451 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
|
General disorders
Death
|
0.25%
1/399 • Number of events 1 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.00%
0/412 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.55%
8/1451 • Number of events 8 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.00%
0/399 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.24%
1/412 • Number of events 1 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.14%
2/1451 • Number of events 2 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
|
Metabolism and nutrition disorders
Diabetes Mellitus Inadequate Control
|
0.50%
2/399 • Number of events 2 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.00%
0/412 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.07%
1/1451 • Number of events 1 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
|
Infections and infestations
Diverticulitis
|
0.25%
1/399 • Number of events 1 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.49%
2/412 • Number of events 2 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.14%
2/1451 • Number of events 2 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.50%
2/399 • Number of events 4 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.97%
4/412 • Number of events 4 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
1.3%
19/1451 • Number of events 19 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.25%
1/399 • Number of events 1 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.24%
1/412 • Number of events 1 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.48%
7/1451 • Number of events 7 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
1.3%
5/399 • Number of events 5 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
1.7%
7/412 • Number of events 7 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
3.0%
44/1451 • Number of events 51 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/399 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.49%
2/412 • Number of events 2 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.41%
6/1451 • Number of events 6 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/399 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.49%
2/412 • Number of events 2 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.48%
7/1451 • Number of events 8 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
|
Nervous system disorders
Headache
|
0.50%
2/399 • Number of events 2 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.24%
1/412 • Number of events 1 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.00%
0/1451 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
|
General disorders
Hernia
|
0.00%
0/399 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.24%
1/412 • Number of events 1 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.83%
12/1451 • Number of events 12 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.25%
1/399 • Number of events 1 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.00%
0/412 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.28%
4/1451 • Number of events 4 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
|
Immune system disorders
Hypersensitivity
|
0.25%
1/399 • Number of events 1 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.00%
0/412 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.07%
1/1451 • Number of events 1 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.25%
1/399 • Number of events 1 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.00%
0/412 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.34%
5/1451 • Number of events 5 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
|
Vascular disorders
Hypotension
|
0.25%
1/399 • Number of events 1 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.24%
1/412 • Number of events 1 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.69%
10/1451 • Number of events 11 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
|
Cardiac disorders
In-Stent Coronary Artery Restenosis
|
0.75%
3/399 • Number of events 3 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
1.5%
6/412 • Number of events 6 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.00%
0/1451 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
|
Infections and infestations
Infection
|
0.00%
0/399 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.73%
3/412 • Number of events 4 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.76%
11/1451 • Number of events 13 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
|
Cardiac disorders
Myocardial Infarction
|
0.75%
3/399 • Number of events 3 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.00%
0/412 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.00%
0/1451 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
|
General disorders
Non-Cardiac Chest Pain
|
0.75%
3/399 • Number of events 3 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
1.2%
5/412 • Number of events 7 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
1.0%
15/1451 • Number of events 16 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.25%
1/399 • Number of events 1 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.73%
3/412 • Number of events 3 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.00%
0/1451 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
|
Vascular disorders
Peripheral Ischaemia
|
0.25%
1/399 • Number of events 1 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.00%
0/412 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.28%
4/1451 • Number of events 4 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
|
Infections and infestations
Pneumonia
|
1.3%
5/399 • Number of events 5 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.49%
2/412 • Number of events 2 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
1.4%
20/1451 • Number of events 26 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
|
Nervous system disorders
Presyncope
|
0.25%
1/399 • Number of events 1 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.00%
0/412 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.07%
1/1451 • Number of events 1 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.00%
0/399 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.24%
1/412 • Number of events 1 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.48%
7/1451 • Number of events 9 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
|
General disorders
Pyrexia
|
0.00%
0/399 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.24%
1/412 • Number of events 1 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.21%
3/1451 • Number of events 3 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.25%
1/399 • Number of events 1 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.00%
0/412 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.28%
4/1451 • Number of events 4 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/399 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.49%
2/412 • Number of events 2 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.96%
14/1451 • Number of events 16 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
|
Gastrointestinal disorders
Retroperitoneal Haemorrhage
|
0.25%
1/399 • Number of events 1 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.00%
0/412 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.07%
1/1451 • Number of events 1 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
|
Surgical and medical procedures
Therapeutic Embolisation
|
0.00%
0/399 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.24%
1/412 • Number of events 1 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.14%
2/1451 • Number of events 2 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
|
Injury, poisoning and procedural complications
Thrombosis In Device
|
0.50%
2/399 • Number of events 2 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.49%
2/412 • Number of events 2 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
1.2%
18/1451 • Number of events 18 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.75%
3/399 • Number of events 3 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.73%
3/412 • Number of events 3 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.21%
3/1451 • Number of events 3 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
|
Infections and infestations
Urinary Tract Infection
|
0.25%
1/399 • Number of events 1 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.24%
1/412 • Number of events 1 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.48%
7/1451 • Number of events 9 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.25%
1/399 • Number of events 1 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.24%
1/412 • Number of events 1 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.00%
0/1451 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
|
Ear and labyrinth disorders
Vertigo
|
0.25%
1/399 • Number of events 1 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.00%
0/412 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.07%
1/1451 • Number of events 1 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
Other adverse events
| Measure |
Placebo Arm
n=399 participants at risk
Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of placebo thienopyridine and aspirin (ASA).
Placebo (12-Month Arm): Placebo
ASA: 75 mg - 325 mg Aspirin(ASA)
|
Thienopyridine Therapy
n=412 participants at risk
Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of active thienopyridine and aspirin (ASA).
Prasugrel and Clopidogrel (30-Month Arm): Prasugrel 5 or 10 mg; Clopidogrel 75 mg
ASA: 75 mg - 325 mg Aspirin(ASA)
|
Surveillance Arm
n=1451 participants at risk
Non randomized subjects followed through 24 months
|
|---|---|---|---|
|
General disorders
Chest Pain
|
0.00%
0/399 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
0.00%
0/412 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
6.2%
90/1451 • Number of events 96 • All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER