Condition category
Circulatory System
Date applied
27/01/2006
Date assigned
27/01/2006
Last edited
11/05/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

Sponsor information

Organisation

Amsterdam Department of Interventional Cardiology (ADIC) (Netherlands)

Sponsor details

P.O. Box 95500
Amsterdam
1090 HM
Netherlands

Sponsor type

Research organisation

Website

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

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19098058

Publication citations

  1. 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.

Additional files

Editorial Notes