Optimal timing of coronary intervention in unstable angina

ISRCTN	ISRCTN80874637
DOI	https://doi.org/10.1186/ISRCTN80874637
Protocol serial number	N/A
Sponsor	Amsterdam Department of Interventional Cardiology (ADIC) (Netherlands)
Funder	Netherlands Heart Foundation (Nederlandse Hartstichting) (Netherlands)

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

Onze Lieve Vrouwe Gasthuis
Research Cardiology
P.O. Box 95500
Amsterdam
1090 HM
Netherlands

Phone	+31 (0)20 5993032
Email	R.K.Riezebos@xs4all.nl

Study information

Primary study design	Interventional
Study design	Multicentre randomised active-controlled parallel group trial
Secondary study design	Randomised controlled trial
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(s)	Composite incidence of death, MI and revascularisation up to 30 days post-enrolment.
Key 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
Completion date	01/01/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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