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

NCT ID: NCT01959451

Last Updated: 2019-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 2600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2017-06-30

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.

Conditions

Acute Coronary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Prasugrel

Prasugrel 5 mg or 10mg daily for 12 months.

Group Type: ACTIVE_COMPARATOR

Prasugrel

Intervention Type: DRUG

see Arm description

Prasugrel/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

Group Type: EXPERIMENTAL

Clopidogrel

Intervention Type: DRUG

see arm description

Interventions

Prasugrel

see Arm description

Intervention Type: DRUG

Clopidogrel

see arm description

Intervention Type: DRUG

Other Intervention Names

Efient; Iscover; Plavix

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LMU Klinikum

OTHER

Sponsor Role: lead

Responsible Party

Dirk Sibbing

Prof. Dr. Dirk Sibbing

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dirk Sibbing, MD

Role: PRINCIPAL_INVESTIGATOR

Munich University Hospital

Julinda Mehilli, MD

Role: PRINCIPAL_INVESTIGATOR

Munich University Hospital

Steffen Massberg, MD

Role: STUDY_CHAIR

Munich University Hospital

Locations

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

Herzzentrum der Universität zu Köln

Cologne, , 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

University Hospital Mainz, Department of Cardiology

Mainz, , Germany

Klinikum Memmingen, Innere Medizin I

Memmingen, , Germany

Munich University Hospital

Munich, , Germany

Klinikum Neuperlach, Department of Cardiology

Munich, , Germany

Klinikum Bogenhausen, Department of Cardiology

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

Tübingen, , Germany

Kliniken Nordoberpfalz AG, Klinikum Weiden, Medizinische Klinik II

Weiden, , Germany

Semmelweis Egyetem Kardiovaszkuláris Centrum

Budapest, , Hungary

Budapest Military Hospital

Budapest, , Hungary

Heart Center Balatonfüred

Budapest, , Hungary

Department of Cardiology Petz Aladár Megyei Oktató Kórház

Győr, , Hungary

Heart Center Kecskemet

Kecskemét, , Hungary

PTE KK Szívgyógyászati Klinika Intervenciós Kardiológia Részleg

Pécs, , Hungary

Heart Center Szeged

Szeged, , Hungary

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, , Poland

Countries

Austria; Germany; Hungary; Poland

References

Sibbing D, Aradi D, Jacobshagen C, Gross L, Trenk D, Geisler T, Orban M, Hadamitzky M, Merkely B, Kiss RG, Komocsi A, Dezsi CA, Holdt L, Felix SB, Parma R, Klopotowski M, Schwinger RHG, Rieber J, Huber K, Neumann FJ, Koltowski L, Mehilli J, Huczek Z, Massberg S; TROPICAL-ACS Investigators. Guided de-escalation of antiplatelet treatment in patients with acute coronary syndrome undergoing percutaneous coronary intervention (TROPICAL-ACS): a randomised, open-label, multicentre trial. Lancet. 2017 Oct 14;390(10104):1747-1757. doi: 10.1016/S0140-6736(17)32155-4. Epub 2017 Aug 28.

Reference Type: DERIVED

PMID: 28855078 (View on PubMed)

Sibbing D, Aradi D, Jacobshagen C, Gross L, Trenk D, Geisler T, Orban M, Gori T, Hadamitzky M, Merkely B, Kiss RG, Komocsi A, Dezsi CA, Thalmeier A, Low A, Holdt L, Teupser D, Ince H, Felix SB, Parma R, Malek L, Horstkotte J, Baylacher M, Schwinger R, Rieber J, Mudra H, Hausleiter J, Huber K, Neumann FJ, Koltowski L, Huczek Z, Mehilli J, Massberg S; TROPICAL-ACS Investigators. A randomised trial on platelet function-guided de-escalation of antiplatelet treatment in ACS patients undergoing PCI. Rationale and design of the Testing Responsiveness to Platelet Inhibition on Chronic Antiplatelet Treatment for Acute Coronary Syndromes (TROPICAL-ACS) Trial. Thromb Haemost. 2017 Jan 5;117(1):188-195. doi: 10.1160/TH16-07-0557. Epub 2016 Sep 22.

Reference Type: DERIVED

PMID: 27652610 (View on PubMed)

Related Links

http://www.ncbi.nlm.nih.gov/pubmed/27652610

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

Other Identifiers

MucT001-13

Identifier Type: -

Identifier Source: org_study_id