Invasive versus Conservative Treatment in Unstable coronary Syndromes
| ISRCTN | ISRCTN82153174 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN82153174 |
| Secondary identifying numbers | NTR442 |
- Submission date
- 27/01/2006
- Registration date
- 27/01/2006
- Last edited
- 15/01/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr RJ de Winter
Scientific
Scientific
Academic Medical Center
Department of Cardiology
B2-137
PO Box 22660
Amsterdam
1100 DD
Netherlands
| r.j.dewinter@amc.uva.nl |
Study information
| Study design | Multicentre randomised open label active controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Invasive versus Conservative Treatment in Unstable coronary Syndromes |
| Study acronym | ICTUS |
| Study objectives | 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. |
| Ethics approval(s) | Received from local medical ethics committee |
| Health condition(s) or problem(s) studied | Acute coronary syndrome |
| 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 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. |
| Intervention type | Other |
| Primary outcome measure | Within one year after randomisation, a composite of: 1. Death 2. Non-fatal myocardial infarction 3. Rehospitalization for anginal symptoms |
| Secondary outcome measures | 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 |
| Overall study start date | 01/07/2001 |
| Completion date | 01/09/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 1200 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/07/2001 |
| Date of final enrolment | 01/09/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Center
Amsterdam
1100 DD
Netherlands
1100 DD
Netherlands
Sponsor information
Interuniversity Cardiology Institute of the Netherlands (ICIN) (Netherlands)
University/education
University/education
PO Box 19258
Utrecht
3501 DG
Netherlands
| Website | http://www.icin.nl |
|---|---|
"ROR" |
https://ror.org/01mh6b283 |
Funders
Funder type
Industry
Medtronic BV (Netherlands)
No information available
Pfizer (Netherlands)
Government organisation / For-profit companies (industry)
Government organisation / For-profit companies (industry)
- Alternative name(s)
- Pfizer Inc., Pfizer Consumer Healthcare, Davis, Charles Pfizer & Company, Warner-Lambert, King Pharmaceuticals, Wyeth Pharmaceuticals, Seagen
- Location
- United States of America
Sanofi-Aventis (Netherlands)
No information available
Eli Lilly (Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 15/09/2005 | Yes | No | |
| Results article | results | 10/03/2007 | Yes | No | |
| Results article | results | 23/02/2008 | Yes | No | |
| Results article | results | 02/03/2010 | Yes | No | |
| Other publications | collaborative analysis | 31/01/2012 | Yes | No | |
| Other publications | collaborative analysis | 01/02/2012 | Yes | No | |
| Results article | substudy results | 15/03/2014 | Yes | No |
