EVOLVE Short DAPT Study

NCT02605447 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2009

Last updated 2020-09-25

Study results available
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Summary

The EVOLVE Short DAPT Study is a prospective, multicenter, single-arm study designed to assess the safety of 3-month DAPT in subjects at high risk for bleeding undergoing PCI with a SYNERGY Stent System.

Conditions

Interventions

DRUG

3 months of dual antiplatelet therapy (DAPT)

3 months of P2Y12 inhibitor (clopidogrel, prasugrel or ticagrelor) plus 15-months of aspirin

DEVICE

SYNERGY Stent System

SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Ajay Kirtane, MD · Columbia University Medical Center/ NewYork Presbyterian Hospital

  • Stephan Windecker, Prof, MD · INSELSPITAL - Universitätsspital Bern

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-16
Primary Completion
2019-07-17
Completion
2019-07-17

Countries

  • United States
  • Brazil
  • Germany
  • Japan
  • Latvia
  • Sweden
  • Switzerland

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02605447 on ClinicalTrials.gov