Comparison of a 12 month vs. a short-term therapy with prasugrel in patients with acute heart attack undergoing coronary stenting

Phase 1

• Conditions: Troponin positive acute coronary syndrome after successful percutaneous coronary intervention with an indication for a standard treatment of 12 month with prasugrel; MedDRA version: 19.1Level: PTClassification code 10051592Term: Acute coronary syndromeSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2013-001636-22-DE
• Lead Sponsor: Hospital of the University of Munich, Grosshadern

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-25
• Last Update Posted: 3 July 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2600

Inclusion Criteria

- Patients with troponin positive ACS
- Successful PCI (defined as a post PCI diameter stenosis <20% and TIMI flow >=2)
- A planned treatment of prasugrel for 12 month after the procedure
- Written informed consent
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 1500
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1100

Exclusion Criteria

- Age < 18 years and > 80 years
- Subjects with known contraindications to clopidogrel treatment, which are hypersensitivity to the drug substance or any component of the product and active pathological bleeding such as peptic ulcer or intracranial hemorrhage
- Subjects with known contraindications to prasugrel treatment, which are hypersensitivity to the drug substance or any component of the product, active pathological bleeding such as peptic ulcer or intracranial hemorrhage and a history of prior transient ischemic attack (TIA) or stroke
- Subjects with a history of a complicated or prolonged cardiogenic shock in the last two weeks prior to the beginning of this clinical trial. A complicated or prolonged cardiogenic shock is defined by a cardiogenic shock that required mechanical ventilation or the cardiovascular support with positive inotropic drugs (i.v. catecholamines) for =7 days.
- Subjects requiring concomitant treatment with an anticoagulant agent (Vitamin-K antagonists or novel oral anticoagulants such as rivaroxaban, dabigatran or apixaban)
- Indication for major surgery (per decision of the treating physician) for the planned duration of the study
- Simultaneous participation in another clinical trial that involveds the administration of an investigational medicinal drug within 30 days prior to the beginning of this clinical trial
- Known or persistent abuse of medication, drugs or alcohol
- Current or planned pregnancy or nursing women, women 90 days after childbirth. Females of childbearing potential, who do not use and are not willing to use medically reliable methods of contraception for the entire study duration (such as oral, injectable, or implantable contraceptives, or intrauterine devices) unless they are surgically sterilized/hysterectomized or there are any other criteria considered sufficiently reliable by the investigator`s opinion
- Evidence of significant active neuropsychiatric disease, in the investigator´s opinion

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified