No registrations found.
ID
Source
Brief title
Health condition
Acute coronary syndromes
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary end point is
1. A composite of death;
2. Nonfatal myocardial infarction;
3. Or rehospitalization for anginal symptoms within one year after randomization.
Secondary outcome
1. The occurrence of the components of the primary endpoint;
2. The occurrence of death or myocardial infarction;
3. A percutaneous coronary intervention;
4. Coronary artery bypass grafting;
5. Functional status after one, six, and twelve months;
6. Two, three and five years follow-up.
Background summary
N/A
Study objective
An early invasive strategy is superior to a selectively invasive strategy for patients who have acute coronary syndromes
without ST-segment elevation and with an elevated cardiac troponin T level.
Intervention
Against a background of optimized medical therapy patients are randomized between an early invasive strategy or a selective invasive strategy.
The early invasive strategy include angiography within 24 to 48 hours after randomization and revascularization when appropriate.
The selective invasive strategy include medical stabilization, with angiography and revascularization only in case of refractory angina or significant ischemia on the pre discharge exercise test.
Department of Cardiology, B2-137,
P.O. Box 22660
R.J. Winter, de
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
r.j.dewinter@amc.uva.nl
Department of Cardiology, B2-137,
P.O. Box 22660
R.J. Winter, de
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
r.j.dewinter@amc.uva.nl
Inclusion criteria
1. Symptoms of ischemia that were increasing or occurred at rest, with the last episode occurring no more than 24 hours before randomization;
- an elevated cardiac troponin T level (≥0.03µg per liter);
2. and either ischemic changes as assessed by electrocardiography (defined as ST-segment depression or transient ST-segment elevation exceeding 0.05 mV,
3. or T-wave inversion of ≥0.2 mV in two contiguous leads)
4. or a documented history of coronary artery disease as evidenced by previous myocardial infarction,
5. findings on previous coronary angiography, or a positive exercise test.
Exclusion criteria
1. Age younger than 18 years or older than 80 years;
2. Myocardial infarction with ST-segment elevation in the past 48 hours;
3. An indication for primary percutaneous coronary intervention or fibrinolytic therapy,
- hemodynamic instability or overt congestive heart failure;
4. The use of oral anticoagulant drugs in the past 7 days,;
5. Fibrinolytic treatment within the past 96 hours;
6. Percutaneous coronary intervention within the past 14 days;
7. A contraindication to treatment with percutaneous coronary intervention or glycoprotein IIb/IIIa inhibitors;
8. Recent trauma or risk of bleeding;
9. Hypertension despite treatment and weight greater than 120 kg.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL401 |
| NTR-old | NTR442 |
| Other | : N/A |
| ISRCTN | ISRCTN82153174 |