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

Brief description of study

The purpose of this randomized clinical trial is 1) to determine if colchicine, a medicine that lowers inflammation, can reduce the incidence of cardiovascular death, myocardial infarction, or stroke, and 2) to determine if spironolactone, a medicine that improves remodeling of the heart muscle, can reduce the incidence of cardiovascular death or new or worsening heart failure in patients with ST-segment elevation myocardial infarction (heart attack that requires immediate stent placement). The purpose of the nested registry is to obtain additional information on the safety and effectiveness of the SYNERGY stent system in patients with ST-segment elevation myocardial infarction (heart attack). Potential subjects for the randomized clinical trial have received any stent for treatment of their heart attack during percutaneous coronary intervention, while potential subjects for the nested registry have received a stent called SYNERGY for treatment of their heart attack during percutaneous coronary intervention. The SYNERGY stent is a drug-eluting stent coated with a bioabsorbable polymer containing a drug called everolimus. Everolimus is released from the stent for about 3 months and the polymer is fully absorbed by the body soon after that. Everolimus stops the abnormal growth and build-up of heart muscle cells in the treated vessel, which prevents re-narrowing of the treated vessel after stent implantation.


Clinical Study Identifier: s18-00119
ClinicalTrials.gov Identifier: NCT03048825
Principal Investigator: Binita Shah
Currently Recruiting

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