CLEAR SYNERGY (OASIS 9)
Research type
Research Study
Full title
CLEAR SYNERGY (OASIS 9): A 2x2 factorial randomized controlled trial of CoLchicine and spironolactonE in patients with ST elevation myocARdial infarction/SYNERGY Stent Registry – Organization to Assess Strategies for Ischemic Syndromes 9
IRAS ID
235872
Contact name
Robert Storey
Contact email
Sponsor organisation
Population Health Research Institute
Eudract number
2017-000487-15
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 2 months, 0 days
Research summary
CLEAR SYNERGY (OASIS) is an international clinical trial evaluating two medications, colchicine and spironolactone, to determine if they can reduce damage to the heart and prevent future cardiovascular events after a heart attack (such as a further heart attack or heart failure). In addition to usual medicines prescribed for this condition, participants in this trial may receive one, both, or neither medication by random assignment.
This study will include patients who have undergone a procedure known as Percutaneous Coronary Intervention (PCI) to treat a type of heart attack called an ST Elevation Myocardial Infarction (STEMI). PCI involves inserting a small tube into an artery in the wrist or groin under local anaesthetic, passing a balloon into the blocked heart artery to open it and implantation of a metal stent into the wall of the artery to keep it open. Usually ‘drug-eluting’ stents are used that have a polymer coating containing a drug, which is released slowly to reduce the risk of the heart artery renarrowing. If patients receive a SYNERGY everolimus-eluting stent during their PCI procedure, they will also be enrolled in the SYNERGY stent registry. The purpose of this observational registry is to collect additional information on the safety and effectiveness of the SYNERGY stent in patients with STEMI.
Patients will attend follow-up visits for a minimum of 12 months to a maximum of 36 months (or common study end date, whichever occurs first).REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
18/LO/0612
Date of REC Opinion
14 May 2018
REC opinion
Further Information Favourable Opinion