Testing Responsiveness to Platelet Inhibition on Chronic Antiplatelet Treatment For Acute Coronary Syndromes Trial

Phase 4

Completed

• Conditions: Acute Coronary Syndrome
• Interventions: Drug: Prasugrel; Drug: Clopidogrel

• Registration Number: NCT01959451
• Lead Sponsor: LMU Klinikum

Brief Summary

This study investigates whether a platelet function testing guided approach with a short-term (1 week) prasugrel treatment and a switch over to clopidogrel treatment in adequate responders to clopidogrel is non-inferior regarding the combined incidence of bleeding and thrombotic complications to a 12 month standard treatment with prasugrel in acute coronary syndrome (ACS) patients treated with percutaneous coronary intervention (PCI).

Detailed Description

Patients suffering of heart attack have highly activated blood platelets. During and after invasive treatment of blocked coronary vessels (percutaneous coronary intervention = PCI) a potent platelet inhibition is needed to reduce the risk of thrombotic complications which is particularly high within the first week after PCI. On the other hand, the use of potent platelet inhibitors such as prasugrel is associated with higher bleeding risk particularly when used at long-term. A combination of a potent antiplatelet drug (prasugrel) within the first week with a less potent antiplatelet drug (clopidogrel) thereafter might lead to a higher net clinical benefit - means less bleeding and thrombotic complications. This hypothesis is being investigated in the current trial.

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-10-08
• Study First Submitted QC: 2013-10-08
• Study First Posted: 2013-10-10
• Primary Completion: 2016-05
• Study Completion: 2017-06
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-28
• Last Update Posted: 2019-03-01

Recruitment & Eligibility

• Status: COMPLETED
• 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 months after the procedure
• written informed consent

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
• Cardiogenic shock
• 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 or participation in any clinical trial involving administration of an investigational medicinal product within 30 days prior to clinical trial beginning
• 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 contraceptive devices) unless they are surgically sterilized / hysterectomized or there are any other criteria considered sufficiently reliable by the investigator in individual cases
• Evidence of significant active neuropsychiatric disease, in the investigator's opinion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prasugrel	Prasugrel	Prasugrel 5 mg or 10mg daily for 12 months.
Prasugrel/Clopidogrel	Clopidogrel	Day 0 - 7 Prasugrel 5 or 10mg Day 8 - 14 Clopidogrel 75mg q/d. On Day 14 platelet function testing Patients with HPR will be switched to Prasugrel the others will remain on Clopidogrel for 11 1/2 months

Primary Outcome Measures

Name	Time	Method
Composite of death from cardiovascular cause, myocardial infarction, stroke and bleeding grade ≥ 2 defined according to BARC criteria	12 months

Secondary Outcome Measures

Name	Time	Method
bleeding events BARC class ≥2	12 months
stent thrombosis	12 months
all-cause death	12 months

Trial Locations

Locations (33)

Medizin-Universität Graz, Univ. Klinik für Innere Medizin; 🇦🇹 Graz, Austria

Wilhelminenspital Wien, 3. Medizinische Abteilung; 🇦🇹 Vienna, Austria

Klinikum Augsburg, Department of Cardiology; 🇩🇪 Augsburg, Germany

Heart Center Bad Krozingen; 🇩🇪 Bad Krozingen, Germany

Asklepios Stadtklinik Bad Tölz, Internal Medicine; 🇩🇪 Bad Tölz, Germany

St. Josef Hospital, Katholisches Klinikum Bochum, Department of Cardiology; 🇩🇪 Bochum, Germany

Universitätsklinikum Frankfurt, Department of Cardiology; 🇩🇪 Frankfurt, Germany

Kliniken Ostallgäu-Kaufbeuren, Klinik Füssen; 🇩🇪 Füssen, Germany

Universitätsmedizin Greifswald, Klinik u. Poliklinik für Innere Medizin B; 🇩🇪 Greifswald, Germany

Heart Center at the University Medical Center Goettingen; 🇩🇪 Göttingen, Germany

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