Testing Responsiveness to Platelet Inhibition on Chronic Antiplatelet Treatment For Acute Coronary Syndromes Trial
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2600
- 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
- 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)
Wilhelminenspital Wien, 3. Medizinische Abteilung
🇦🇹Vienna, Austria
Medizin-Universität Graz, Univ. Klinik für Innere Medizin
🇦🇹Graz, Austria
Heart Center Szeged
🇭🇺Szeged, Hungary
Universitätsklinikum Frankfurt, Department of Cardiology
🇩🇪Frankfurt, Germany
University Hospital Mainz, Department of Cardiology
🇩🇪Mainz, Germany
St. Josef Hospital, Katholisches Klinikum Bochum, Department of Cardiology
🇩🇪Bochum, Germany
Munich University Hospital
🇩🇪Munich, Germany
Semmelweis Egyetem Kardiovaszkuláris Centrum
🇭🇺Budapest, Hungary
Heart Center Balatonfüred
🇭🇺Budapest, Hungary
Heart Center Kecskemet
🇭🇺Kecskemet, Hungary
PTE KK Szívgyógyászati Klinika Intervenciós Kardiológia Részleg
🇭🇺Pecs, Hungary
3rd Department of Cardiology, Upper Silesian Medical Centre, Medical University of Silesia, Katowice
🇵🇱Katowice, Poland
Universitätsmedizin Greifswald, Klinik u. Poliklinik für Innere Medizin B
🇩🇪Greifswald, Germany
Helios-Klinikum Siegburg, Abteilung für Kardiologie und Angiologie
🇩🇪Siegburg, Germany
1st Department of Cardiology, Poznan University of Medical Science
🇵🇱Poznan, Poland
Heart Center Bad Krozingen
🇩🇪Bad Krozingen, Germany
Asklepios Stadtklinik Bad Tölz, Internal Medicine
🇩🇪Bad Tölz, Germany
Budapest Military Hospital
🇭🇺Budapest, Hungary
Kliniken Ostallgäu-Kaufbeuren, Klinik Füssen
🇩🇪Füssen, Germany
University Hospital of Tuebingen, Department of Cardiology
🇩🇪Tuebingen, Germany
Klinikum Neuperlach, Department of Cardiology
🇩🇪Munich, Germany
Department of Cardiology Petz Aladár Megyei Oktató Kórház
🇭🇺Györ, Hungary
1st Department of Cardiology, Medical University of Warsaw
🇵🇱Warsaw, Poland
Department of Interventional Cardiology and Angiology, Institute of Cardiology, Warsaw
🇵🇱Warsaw, Poland
Klinikum Augsburg, Department of Cardiology
🇩🇪Augsburg, Germany
Heart Center at the University Medical Center Goettingen
🇩🇪Göttingen, Germany
Klinikum Memmingen, Innere Medizin I
🇩🇪Memmingen, Germany
Universitätsmedizin Rostock, Zentrum für Innere Medizin
🇩🇪Rostock, Germany
Herzzentrum der Universität zu Köln
🇩🇪Köln, Germany
Universitäres Herzzentrum Hamburg, UKE
🇩🇪Hamburg, Germany
Klinikum Bogenhausen, Department of Cardiology
🇩🇪Munich, Germany
Klinikum Oldenburg gGmbH, Herz-Kreislauf-Zentrum, Klinik für Kardiologie
🇩🇪Oldenburg, Germany
Kliniken Nordoberpfalz AG, Klinikum Weiden, Medizinische Klinik II
🇩🇪Weiden, Germany