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Ticagrelor or Prasugrel Versus Clopidogrel in Elderly Patients With an Acute Coronary Syndrome and a High Bleeding Risk: Optimization of Antiplatelet Treatment in High-risk Elderly

NCT02317198 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1011

Last updated 2024-05-30

No results posted yet for this study

Summary

A randomized controlled, open label, multicenter trial with 1000 patients aged 70 years and older, presenting with Non-ST-elevation acute coronary syndrome. Patients will be randomized to either clopidogrel or the novel P2Y12 inhibitor (ticagrelor or prasugrel). Patients will be followed for one year for outcomes such as bleeding episode requiring medical intervention and net clinical benefit (all cause mortality, non-fatal myocardial infarction, non-fatal stroke, PLATO major and minor bleeding).

Conditions

  • Non-ST-elevation Acute Coronary Syndrome
  • Unstable Angina
  • Non-ST-elevation Myocardial Infarction

Interventions

DRUG

Clopidogrel

DRUG

Ticagrelor or Prasugrel

Sponsors & Collaborators

  • UMC Utrecht

    collaborator OTHER

  • Leiden University Medical Center

    collaborator OTHER

  • Meander Medical Center

    collaborator OTHER

  • Medical Center Alkmaar

    collaborator OTHER

  • Isala

    collaborator OTHER

  • Gelre Hospitals

    collaborator OTHER

  • Gelderse Vallei Hospital

    collaborator OTHER

  • Frisius Medisch Centrum

    collaborator OTHER

  • Rijnstate Hospital

    collaborator OTHER

  • St. Antonius Hospital

    lead OTHER

Principal Investigators

  • Jurriën M ten Berg, MD, PhD · St. Antonius Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2018-11-30
Completion
2019-11-30

Countries

  • Netherlands

Study Locations

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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 NCT02317198 on ClinicalTrials.gov