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Randomized, Open Label Trial of 6 Months Versus 12 Months DAPT After Drug-Eluting Stent in STEMI

NCT01459627 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1100

Last updated 2017-09-07

No results posted yet for this study

Summary

OBJECTIVE OF THE STUDY: To test the hypothesis that 6 months DAPT (Dual anti-platelet therapy) after second generation DES (Drug Eluting Stent) implantation in STEMI (ST elevation Myocardial Infarction) is not inferior to 12 months DAPT in terms of clinical outcomes (composite endpoint of all-cause mortality, any MI, any revascularization, stroke and major bleeding at 18 months after randomization).

The trial will incorporate two registers studying respectively the safety outcomes of Bivalirudin and Prasugrel combination and Bivalirudin and Ticagrelor combination at 2 and 30 days. Finally the trial design permits assessment of the clinical outcomes after primary PCI for treatment of STEMI with the new Resolute Integrity (Medtronic Santa Rosa Ca, USA) stent at 30 days and 6 months.

Conditions

Interventions

OTHER

6 months DAPT

Dual antiplatelet therapy will be stopped at randomisation to the 6 months DAPT group. Patients will be treated from 6 months onwards only with ASA.

OTHER

12 months DAPT

Dual antiplatelet therapy will be continued till 12 months after enrollment in the study

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Maasstad Hospital

    lead OTHER

Principal Investigators

  • Elvin Kedhi, MD PHD · Isala

  • Martin van der Ent, MD PhD · Maasstadhospital / MCR B.V.

  • Clemens von Birgelen, MD PhD · Medisch Spectrum Twente

  • Felix Zijlstra, MD PhD · Erasmus Medisch Centrum

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2017-08-31
Completion
2017-08-31

Countries

  • Netherlands
  • Norway
  • Poland
  • Switzerland

Study Locations

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Entities

Diseases
Companies

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 NCT01459627 on ClinicalTrials.gov