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Optimal timing of coronary intervention in unstable angina
ISRCTN ISRCTN80874637
DOI 10.1186/ISRCTN80874637
ClinicalTrials.gov identifier
EudraCT number
Public title Optimal timing of coronary intervention in unstable angina
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
Acronym OPTIMA
Serial number at source N/A
Study hypothesis 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.
Lay summary
Ethics approval Received from local medical ethics committee
Study design Multicentre randomised active-controlled parallel group trial
Countries of recruitment Netherlands
Disease/condition/study domain Non ST-Elevation Acute Coronary Syndrome (NSTE-ACS)
Participants - 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
Participants - 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
Anticipated start date 01/01/2004
Anticipated end date 01/01/2008
Status of trial Completed
Patient information material
Target number of participants 600
Interventions 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.
Primary outcome measure(s) Composite incidence of death, MI and revascularisation up to 30 days post-enrolment.
Secondary outcome measure(s) 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
Sources of funding Netherlands Heart Foundation (Nederlandse Hartstichting) (Netherlands)
Trial website
Publications 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19098058
Contact name Dr  Robert K.  Riezebos
  Address Onze Lieve Vrouwe Gasthuis
Research Cardiology
P.O. Box 95500
  City/town Amsterdam
  Zip/Postcode 1090 HM
  Country Netherlands
  Tel +31 (0)20 5993032
  Fax +31 (0)20 5993997
  Email R.K.Riezebos@xs4all.nl
Sponsor Amsterdam Department of Interventional Cardiology (ADIC) (Netherlands)
  Address P.O. Box 95500
  City/town Amsterdam
  Zip/Postcode 1090 HM
  Country Netherlands
Date applied 27/01/2006
Last edited 11/05/2009
Date ISRCTN assigned 27/01/2006
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