Peri-interventional intensified versus moderate platelet inhibition in patients with coronary artery disease without myocardial infarction

Intensified Loading with Prasugrel versus Moderate Loading with Clopidogrel in PCI-treated Patients with Biomarker-Negative Angina pectoris.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-002171-29-DE

Enrollment

2240

Registered

2015-04-13

Start date

2015-07-16

Completion date

Unknown

Last updated

2020-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biomarker-negative patients with an indication for percutaneous coronary intervention MedDRA version: 20.0 Level: PT Classification code 10011078 Term: Coronary artery disease System Organ Class: 10007541 - Cardiac disorders MedDRA version: 20.0 Level: LLT Classification code 10074572 Term: Multiple vessel coronary artery disease System Organ Class: 10007541 - Cardiac disorders

Interventions

Trade Name: Efient Pharmaceutical Form: Film-coated tablet INN or Proposed INN: PRASUGREL CAS Number: 150322-43-3 Other descriptive name: Efient Concentration unit: mg milligram(s) Concentration type:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with biomarker negative unstable angina or patients with stable angina undergoing PCI Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 900 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1340

Exclusion criteria

Exclusion criteria: Age>80 or <18, biomarker positive acute coronary syndrome contraindications to the investigational drugs (prasugrel, clopidogrel)

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the efficacy of intensified loading with single oral administration of 60 mg prasugrel compared to loading with high-dose 600 mg clopidogrel in patients with biomarker negative angina undergoing PCI regarding the clinical outcomes at 30-day after index PCI ;Secondary Objective: to assess safety of intensified loading with prasugrel in comparison to clopidogrel ;Primary end point(s): Combined outcome of all-cause death, any myocardial infarction, stent thrombosis, urgent revascularization and stroke up to 30 days after randomization;Timepoint(s) of evaluation of this end point: 30-day after index PCI	—

Measure

Time frame

Main Objective: To assess the efficacy of intensified loading with single oral administration of 60 mg prasugrel compared to loading with high-dose 600 mg clopidogrel in patients with biomarker negative angina undergoing PCI regarding the clinical outcomes at 30-day after index PCI ;Secondary Objective: to assess safety of intensified loading with prasugrel in comparison to clopidogrel ;Primary end point(s): Combined outcome of all-cause death, any myocardial infarction, stent thrombosis, urgent revascularization and stroke up to 30 days after randomization;Timepoint(s) of evaluation of this end point: 30-day after index PCI

—

Secondary

Measure	Time frame
Secondary end point(s): 1. Bleeding complication BARC =2; 2. Non-CABG TIMI major and minor bleeding; 3. Incidence of peri-PCI MI Type 4a (according to Third Universal Definition of MI); 4) individual components of primary endpoint;Timepoint(s) of evaluation of this end point: 30-day after index PCI	—

Countries

Germany, Hungary

Contacts

Public ContactI. Med. Klinik und Poliklinik

University Hospital of Munich, Grosshadern

julinda.mehilli@med.uni-muenchen.de+4989440073053

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026