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

Acute Coronary Syndrome Clinical Trial

— TROPICAL-ACS  

Official title:

Platelet Function Guided Prasugrel Therapy in ACS Patients Undergoing PCI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01959451
• Other study ID #: MucT001-13
• Status: Completed
• Phase: Phase 4
• Start date: September 2013
• Est. completion date: June 2017

Study information

• Verified date: February 2019
• Source: Klinikum der Universitaet Muenchen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 2600
• Est. completion date: June 2017
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Drug:
• Prasugrel
see Arm description
• Clopidogrel
see arm description

Locations

Country	Name	City	State
Austria	Medizin-Universität Graz, Univ. Klinik für Innere Medizin	Graz
Austria	Wilhelminenspital Wien, 3. Medizinische Abteilung	Vienna
Germany	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	Heart Center at the University Medical Center Goettingen	Göttingen
Germany	Universitätsmedizin Greifswald, Klinik u. Poliklinik für Innere Medizin B	Greifswald
Germany	Universitäres Herzzentrum Hamburg, UKE	Hamburg
Germany	Herzzentrum der Universität zu Köln	Köln
Germany	University Hospital Mainz, Department of Cardiology	Mainz
Germany	Klinikum Memmingen, Innere Medizin I	Memmingen
Germany	Klinikum Bogenhausen, Department of Cardiology	Munich
Germany	Klinikum Neuperlach, Department of Cardiology	Munich
Germany	Munich University Hospital	Munich
Germany	Klinikum Oldenburg gGmbH, Herz-Kreislauf-Zentrum, Klinik für Kardiologie	Oldenburg
Germany	Universitätsmedizin Rostock, Zentrum für Innere Medizin	Rostock
Germany	Helios-Klinikum Siegburg, Abteilung für Kardiologie und Angiologie	Siegburg
Germany	University Hospital of Tuebingen, Department of Cardiology	Tuebingen
Germany	Kliniken Nordoberpfalz AG, Klinikum Weiden, Medizinische Klinik II	Weiden
Hungary	Budapest Military Hospital	Budapest
Hungary	Heart Center Balatonfüred	Budapest
Hungary	Semmelweis Egyetem Kardiovaszkuláris Centrum	Budapest
Hungary	Department of Cardiology Petz Aladár Megyei Oktató Kórház	Györ
Hungary	Heart Center Kecskemet	Kecskemet
Hungary	PTE KK Szívgyógyászati Klinika Intervenciós Kardiológia Részleg	Pecs
Hungary	Heart Center Szeged	Szeged
Poland	3rd Department of Cardiology, Upper Silesian Medical Centre, Medical University of Silesia, Katowice	Katowice
Poland	1st Department of Cardiology, Poznan University of Medical Science	Poznan
Poland	1st Department of Cardiology, Medical University of Warsaw	Warsaw
Poland	Department of Interventional Cardiology and Angiology, Institute of Cardiology, Warsaw	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Klinikum der Universitaet Muenchen

Countries where clinical trial is conducted

Austria,  Germany,  Hungary,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	economic impact of a platelet function testing guided tailored treatment for ACS patients		12 months
Primary	Composite of death from cardiovascular cause, myocardial infarction, stroke and bleeding grade = 2 defined according to BARC criteria		12 months
Secondary	bleeding events BARC class =2		12 months
Secondary	stent thrombosis		12 months
Secondary	all-cause death		12 months

External Links

•   Rationale and design of the Testing Responsiveness to Platelet Inhibition on Chronic Antiplatelet Treatment for Acute Coronary Syndromes (TROPICAL-ACS) Trial