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11 February 2012
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| [ Print-friendly version ] |
| Invasive versus Conservative Treatment in Unstable coronary Syndromes |
| ISRCTN | ISRCTN82153174 |
| ClinicalTrials.gov identifier | |
| Public title | Invasive versus Conservative Treatment in Unstable coronary Syndromes |
| Scientific title | |
| Acronym | ICTUS |
| Serial number at source | NTR442 |
| Study hypothesis | 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. |
| Lay summary | |
| Ethics approval | Received from local medical ethics committee |
| Study design | Multicentre randomised open label active controlled parallel group trial |
| Countries of recruitment | Netherlands |
| Disease/condition/study domain | Acute coronary syndrome |
| Participants - 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
2. An elevated cardiac troponin T level (>/= 0.03 ug per litre) 3. Either ischemic changes as assessed by electrocardiography defined as ST-segment depression or transient ST-segment elevation exceeding 0.05 mV 4. Or T-wave inversion of >/= 0.2 mV in two contiguous leads 5. Or a documented history of coronary artery disease as evidenced by previous myocardial infarction 6. Findings on previous coronary angiography, or a positive exercise test |
| Participants - 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 4. Hemodynamic instability or overt congestive heart failure 5. The use of oral anticoagulant drugs in the past 7 days 6. Fibrinolytic treatment within the past 96 hours 7. Percutaneous coronary intervention within the past 14 days 8. A contraindication to treatment with percutaneous coronary intervention or glycoprotein IIb/IIIa inhibitors 9. Recent trauma or risk of bleeding 10. Hypertension despite treatment and weight greater than 120 kg |
| Anticipated start date | 01/07/2001 |
| Anticipated end date | 01/09/2008 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 1200 |
| Interventions |
Against a background of optimized medical therapy patients are randomized between an early invasive strategy or a selective invasive strategy.
The early invasive strategy includes angiography within 24 to 48 hours after randomization and revascularization when appropriate. The selective invasive strategy includes medical stabilization, with angiography and revascularization only in case of refractory angina or significant ischemia on the pre-discharge exercise test. |
| Primary outcome measure(s) |
Within one year after randomisation, a composite of:
1. Death 2. Non-fatal myocardial infarction 3. Rehospitalization for anginal symptoms |
| Secondary outcome measure(s) |
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 |
| Sources of funding |
1. Medtronic BV (Netherlands)
2. Pfizer (Netherlands) 3. Sanofi-Aventis (Netherlands) 4. Eli Lilly (Netherlands) |
| Trial website | |
| Publications |
1. 2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16162880
2. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17350451 3. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/20045278 |
| Contact name | Dr RJ de Winter |
| Address |
Academic Medical Center
Department of Cardiology B2-137 PO Box 22660 |
| City/town | Amsterdam |
| Zip/Postcode | 1100 DD |
| Country | Netherlands |
| r.j.dewinter@amc.uva.nl | |
| Sponsor | Interuniversity Cardiology Institute of the Netherlands (ICIN) (Netherlands) |
| Address | PO Box 19258 |
| City/town | Utrecht |
| Zip/Postcode | 3501 DG |
| Country | Netherlands |
| Sponsor website: | http://www.icin.nl |
| Date applied | 27/01/2006 |
| Last edited | 07/01/2010 |
| Date ISRCTN assigned | 27/01/2006 |
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| © 2012 ISRCTN unless otherwise stated. | |
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