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EVOLVE Short DAPT – 3 Month Dual Antiplatelet Therapy (DAPT) with SYNERGYTM Stent System

Study Type/Phase: Interventional
Status: Not Recruiting

This is a prospective, multicenter study designed to assess the safety of 3-month dual antiplatelet therapy (DAPT) in subjects at high risk for bleeding undergoing percutaneous coronary intervention (PCI) with the SYNERGY™ Everolimus-Eluting Platinum Chromium Coronary Stent System (Synergy Stent System).

Coronary artery disease is a narrowing of one or more blood vessels (coronary arteries) that supply blood and oxygen to the heart. Coronary stenting is a commonly used procedure to treat coronary artery disease. A stent is a small mesh tube that is placed in the artery through a catheter or PCI to treat weak or narrowed arteries. The FDA approved SYNERGY stent is a drug-eluding stent that has been shown to promote healing and prevent re-narrowing of the coronary arteries. The purpose of this study will be to research the safety of aspirin plus 3 months of a second blood thinner (antiplatelet) medication [clopidogrel (Plavix), or prasugrel (Effient), or ticagrelor (Brilinta)] in people who have a SYNERGY stent.

Speak with your doctor to determine whether you meet the following criteria for participation in this study.

Inclusion Criteria Exclusion Criteria
  • Considered at high risk for bleeding
  • ≥ 75 years of age
  • Need for continued anticoagulation therapy
  • History of major bleeding
  • History of stroke
  • Renal insufficiency or dialysis dependent
  • Must have SYNERGY stent placement within the preceding 3 calendar days of study enrollment
  • Must be able to take the required antiplatelet therapy
  • Willing to comply with study requirements to stop taking P@Y12 inhibitor at the 3-month milestone, if eligible.

 

Principal Investigator

Chad Rammohan, MD

Sponsor

Boston Scientific

NCT Number

NCT02605447

Contact

Kara Turner, Clinical Research Coordinator
Taft Center for Clinical Research
650-962-4562
Kara_Turner@elcaminohealth.org

 

For more information about this clinical trial, including trial status, eligibility and full trial listing, visit www.clinicaltrials.gov.

 

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