Contact information
Type
Scientific
Primary contact
Dr Robert K. Riezebos
ORCID ID
Contact details
Onze Lieve Vrouwe Gasthuis
Research Cardiology
P.O. Box 95500
Amsterdam
1090 HM
Netherlands
+31 (0)20 5993032
R.K.Riezebos@xs4all.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
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
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.
Ethics approval
Received from local medical ethics committee
Study design
Multicentre randomised active-controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
01/01/2004
Overall trial end date
01/01/2008
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
600
Participant 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
Recruitment start date
01/01/2004
Recruitment end date
01/01/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
Onze Lieve Vrouwe Gasthuis
Amsterdam
1090 HM
Netherlands
Funders
Funder type
Research organisation
Funder name
Netherlands Heart Foundation (Nederlandse Hartstichting) (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19098058
Publication citations
-
Results
Riezebos RK, Ronner E, Ter Bals E, Slagboom T, Smits PC, ten Berg JM, Kiemeneij F, Amoroso G, Patterson MS, Suttorp MJ, Tijssen JG, Laarman GJ, , Immediate versus deferred coronary angioplasty in non-ST-segment elevation acute coronary syndromes., Heart, 2009, 95, 10, 807-812, doi: 10.1136/hrt.2008.154815.