Optimal timing of coronary intervention in unstable angina
| ISRCTN | ISRCTN80874637 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN80874637 |
| Secondary identifying numbers | N/A |
- Submission date
- 27/01/2006
- Registration date
- 27/01/2006
- Last edited
- 11/05/2009
- 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 Robert K. Riezebos
Scientific
Scientific
Onze Lieve Vrouwe Gasthuis
Research Cardiology
P.O. Box 95500
Amsterdam
1090 HM
Netherlands
| Phone | +31 (0)20 5993032 |
|---|---|
| R.K.Riezebos@xs4all.nl |
Study information
| Study design | Multicentre randomised active-controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | A randomised clinical trial examining the outcome of immediate versus early (24 to 48 hours) percutaneous coronary intervention in patients with an acute coronary syndrome without persistent ST-segment elevation |
| Study acronym | OPTIMA |
| Study objectives | Immediate percutaneous coronary intervention (PCI) in patients with non-ST elevation acute coronary syndrome (NSTE-ACS) is superior to early PCI with respect to 30-day size and occurrence of (non-STE) myocardial infarction, death and revascularisation. |
| Ethics approval(s) | Received from local medical ethics committee |
| Health condition(s) or problem(s) studied | Non ST-Elevation Acute Coronary Syndrome (NSTE-ACS) |
| Intervention | Patients admitted with NSTE-ACS who are eligible for PCI with stent implantation (as noted after angiography) will be randomised into one of the following treatment arms in this trial: 1. Immediate PCI 2. Early PCI (less than 48 hours after admission, but after 24 hours) All patients will receive drug eluting stents and platelet IIb/IIIa blockers to at least 12 hours after PCI is administered. |
| Intervention type | Other |
| Primary outcome measure | Composite incidence of death, MI and revascularisation up to 30 days post-enrolment. |
| Secondary outcome measures | 1. Size of MI during initial hospitalisation, quantified as peak CK-MB (mass), cumulative positive CK-MBs 2. Six month angiographic restenosis as a composite endpoint with MI and death 3. Incidence of individual and composite endpoints at 30 days and 6 and 12 months including recurrent NSTE-ACS 4. Any revascularisation and/or restenosis (TVR) up to 6 months 5. Re-hospitalisation because of coronary artery disease (CAD) 6. Incidence of major haemorrhage up to 30 days 7. Hospital costs |
| Overall study start date | 01/01/2004 |
| Completion date | 01/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 600 |
| Key inclusion criteria | 1. Aged greater than 21 years 2. Typical chest pain for angina pectoris lasting at least 10 minutes, within last 6 hours 3. No contra-indication to PCI And at least one of the following criteria: 4. 1 mm of horizontal or downsloping ST depression 5. Dynamic ST- or T-wave changes greater than 1 mm in two contiguous leads 6. Elevated troponin or creatine kiase myocardial bands (CK-MB) 7. Known coronary artery disease 8. Two of following risk factors: diabetes mellitus (DM), known hypertension, current smoking, family hx, hypercholesterolaemia, peripheral artery disease, age over 60 years |
| Key exclusion criteria | 1. Chest pain suspected not to be caused by coronary artery disease (CAD) 2. Acute myocardial infarction requiring reperfusion therapy 3. Thrombolytic therapy less than 24 hours/indication for thrombolytic therapy 4. Recent PCI (less than 14 days) 5. Thrombopaenia (less than 100 x 10^12/mm3) 6. Severe bleeding less than 6 weeks 7. Major surgery less than 6 weeks 8. Cerebral haemorrhage in medical history 9. High blood pressure left untreated (diastolic greater than 100 mmHg, systolic greater than 180 mmHg) 10. Life expectancy less than 1 year due to co-morbidity 11. Known intracranial malformation or neoplasm 12. Participation in other study possibly interfering with the endpoints 13. Inability to follow up 14. Culprit lesion is a restenotic lesion |
| Date of first enrolment | 01/01/2004 |
| Date of final enrolment | 01/01/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Onze Lieve Vrouwe Gasthuis
Amsterdam
1090 HM
Netherlands
1090 HM
Netherlands
Sponsor information
Amsterdam Department of Interventional Cardiology (ADIC) (Netherlands)
Research organisation
Research organisation
P.O. Box 95500
Amsterdam
1090 HM
Netherlands
"ROR" |
https://ror.org/01d02sf11 |
|---|
Funders
Funder type
Research organisation
Netherlands Heart Foundation (Nederlandse Hartstichting) (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 | 01/05/2009 | Yes | No |
