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

Phase 4

Completed

• Conditions: Non-ST-elevation Myocardial Infarction; Unstable Angina; Non-ST-elevation Acute Coronary Syndrome
• Interventions: Drug: Ticagrelor or Prasugrel; Drug: Clopidogrel

• Registration Number: NCT02317198
• Lead Sponsor: St. Antonius Hospital

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2014-10-10
• Study First Submitted QC: 2014-12-10
• Study First Posted: 2014-12-15
• Primary Completion: 2018-11
• Study Completion: 2019-11
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-29
• Last Update Posted: 2024-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1011

Inclusion Criteria

• At least 70 years of age.
• Hospitalization for NSTEMI or UA < 72 hours

Exclusion Criteria

• Contraindication to P2Y12 inhibitors i.e. clopidogrel, prasugrel or ticagrelor:
• Unable or unwilling to give informed consent or have a life expectancy of less than one year.
• Having received thrombolytic therapy within the previous 24 hours.
• Severe renal function impairment needing dialysis.
• Confirmed or persistent severe hypertension (Systolic Blood Pressure (SBP) > 180 mmHg and/or Diastolic Blood Pressure (DBP) >110 mmHg) at randomization.
• At increased bleeding risk, at the investigator's opinion, e.g. because of malignancy.
• Cardiogenic shock (SBP ≤ 80mmHg for >30 mins) or Intra-Aortic Balloon Pump (IABP) at the time of screening.
• History of major surgery, severe trauma, fracture or organ biopsy within 90 days prior to randomisation.
• Clinically significant out of range values for platelet count or haemoglobin at screening, in the investigator's opinion.
• ACS under dual antiplatelet therapy, e.g. aspirin with a P2Y12 inhibitor; clopidogrel, prasugrel, ticagrelor.
• Patients with a known CYP2C19 genotype at the time of randomization.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Ticagrelor or Prasugrel	Ticagrelor/Prasugrel
Intervention	Clopidogrel	Clopidogrel

Primary Outcome Measures

Name	Time	Method
occurrence of any bleeding episode requiring medical intervention at 1 year after randomisation	One year
net clinical benefit at 1 year after randomisation	One year	All cause mortality, non-fatal myocardial infarction, non-fatal stroke, PLATO major and minor bleeding

Trial Locations

Locations (1)

St. Antonius hospital; 🇳🇱 Nieuwegein, Utrecht, Netherlands