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Invasive versus Conservative Treatment in Unstable coronary Syndromes.


- candidate number1563
- NTR NumberNTR442
- ISRCTNISRCTN82153174
- Date ISRCTN created27-jan-2006
- date ISRCTN requested18-nov-2005
- Date Registered NTR12-dec-2005
- Secondary IDsN/A 
- Public TitleInvasive versus Conservative Treatment in Unstable coronary Syndromes.
- Scientific TitleInvasive versus Conservative Treatment in Unstable coronary Syndromes.
- ACRONYMICTUS
- hypothesisAn 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.
- Healt Condition(s) or Problem(s) studiedAcute coronary syndrome (ACS)
- Inclusion criteria1. 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 (≥0.03g 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-jul-2001
- planned closingdate1-sep-2008
- Target number of participants1200
- InterventionsAgainst 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.
- Primary outcomeThe 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 outcome1. 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.
- Timepoints
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDr. R.J. Winter, de
- CONTACT for SCIENTIFIC QUERIESDr. R.J. Winter, de
- Sponsor/Initiator Interuniversity Cardiology Institute of the Netherlands (ICIN)
- Funding
(Source(s) of Monetary or Material Support)
Pfizer, Eli Lilly Nederland B.V., Sanofi-Aventis, Medtronic BV.
- Publicationsde Winter RJ, Windhausen F, Cornel JH et al. Early invasive versus selectively invasive management for acute coronary syndromes. N Engl J Med. 2005; 353(11): 1095-104
- Brief summaryN/A
- Main changes (audit trail)
- RECORD12-sep-2005 - 7-mrt-2006


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