Testing Responsiveness to Platelet Inhibition on Chronic Antiplatelet Treatment For Acute Coronary Syndromes Trial (TROPICAL-ACS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 by Klinikum der Universitaet Muenchen
Sponsor:
Information provided by (Responsible Party):
Klinikum der Universitaet Muenchen
ClinicalTrials.gov Identifier:
NCT01959451
First received: October 8, 2013
Last updated: March 26, 2015
Last verified: March 2015
  Purpose

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).


Condition Intervention Phase
Acute Coronary Syndrome
Drug: Prasugrel
Drug: Clopidogrel
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Platelet Function Guided Prasugrel Therapy in ACS Patients Undergoing PCI

Resource links provided by NLM:


Further study details as provided by Klinikum der Universitaet Muenchen:

Primary Outcome Measures:
  • Composite of death from cardiovascular cause, myocardial infarction, stroke and bleeding grade ≥ 2 defined according to BARC criteria [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • bleeding events BARC class ≥2 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • stent thrombosis [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • all-cause death [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • economic impact of a platelet function testing guided tailored treatment for ACS patients [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 2600
Study Start Date: September 2013
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Prasugrel
Prasugrel 5 mg or 10mg daily for 12 months.
Drug: Prasugrel
see Arm description
Other Name: Efient
Experimental: 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
Drug: Clopidogrel
see arm description
Other Names:
  • Iscover
  • Plavix

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01959451

Contacts
Contact: Dirk Sibbing, MD +49 89 44007 ext 3028 dirk.sibbing@med.uni-muenchen.de
Contact: Julinda Mehilli, MD +49 89 44007 ext 3053 julinda.mehilli@med.uni-muenchen.de

Locations
Austria
Medizin-Universität Graz, Univ. Klinik für Innere Medizin Recruiting
Graz, Austria, 8036
Contact: Robert Zweiker, MD       robert.zweiker@medunigraz.at   
Principal Investigator: Robert Zweiker         
Wilhelminenspital Wien, 3. Medizinische Abteilung Recruiting
Vienna, Austria, 1160
Contact: Kurt Huber, MD         
Principal Investigator: Kurt Huber, MD         
Germany
Klinikum Augsburg, Department of Cardiology Recruiting
Augsburg, Germany, 86156
Contact: Wolfgang von Scheidt, MD       wolfgang.scheidt@klinikum-augsburg.de   
Principal Investigator: Wolfgang von Scheidt, MD         
Heart Center Bad Krozingen Recruiting
Bad Krozingen, Germany, 79189
Contact: Dietmar Trenk, MD       Dietmar.Trenk@universitaets-herzzentrum.de   
Principal Investigator: Dietmar Trenk, MD         
Asklepios Stadtklinik Bad Tölz, Internal Medicine Recruiting
Bad Tölz, Germany, 83646
Contact: Hans Ulrich Kreider-Stempfle, MD       u.stempfle@asklepios.com   
Principal Investigator: Hans Ulrich Kreider-Stempfle, MD         
St. Josef Hospital, Katholisches Klinikum Bochum, Department of Cardiology Recruiting
Bochum, Germany, 44791
Contact: Andreas Mügge, MD       a.muegge@klinikum-bochum.de   
Principal Investigator: Andreas Mügge, MD         
Universitätsklinikum Frankfurt, Department of Cardiology Recruiting
Frankfurt, Germany, 60590
Contact: Stephan Fichtlscherer, MD       fichtlscherer@em.uni-frankfurt.de   
Principal Investigator: Stephan Fichtlscherer, MD         
Kliniken Ostallgäu-Kaufbeuren, Klinik Füssen Recruiting
Füssen, Germany, 87629
Contact: Andreas Koenig, MD       andreas.koenig@kliniken-oal-kf.de   
Principal Investigator: Andreas Koenig, MD         
Heart Center at the University Medical Center Goettingen Recruiting
Goettingen, Germany, 37075
Contact: Claudius Jacobshagen, MD       jacobshagen@med.uni-goettingen.de   
Principal Investigator: Claudius Jacobshagen, MD         
Universitätsmedizin Greifswald, Klinik u. Poliklinik für Innere Medizin B Recruiting
Greifswald, Germany, 17475
Contact: Astrid Hummel, MD       Hummel@uni-greifswald.de   
Principal Investigator: Astrid Hummel, MD         
Universitäres Herzzentrum Hamburg, UKE Recruiting
Hamburg, Germany, 20246
Contact: Mahir Karakas, MD       m.karakas@uke.de   
Principal Investigator: Mahir Karakas, MD         
Herzzentrum der Universität zu Köln Recruiting
Köln, Germany, 50937
Contact: Tanja Rudolph, MD       tanja.rudolph@uk-koeln.de   
Principal Investigator: Tanja Rudolph, MD         
University Hospital Mainz, Department of Cardiology Recruiting
Mainz, Germany, 55131
Contact: Tomasso Gori, MD       Tommaso.Gori@unimedizin-mainz.de   
Principal Investigator: Tomasso Gori, MD         
Klinikum Memmingen, Innere Medizin I Recruiting
Memmingen, Germany, 87700
Contact: Andreas May, MD       Andreas.May@klinikum-memmingen.de   
Principal Investigator: Andreas May, MD         
Klinikum Bogenhausen, Department of Cardiology Recruiting
Munich, Germany, 81925
Contact: Johannes Rieber, MD       Johannes.Rieber@klinikum-muenchen.de   
Principal Investigator: Johannes Rieber, MD         
Klinikum Neuperlach, Department of Cardiology Recruiting
Munich, Germany, 81737
Contact: Harald Mudra, MD       harald.mudra@klinikum-muenchen.de   
Principal Investigator: Harald Mudra, MD         
Munich University Hospital Recruiting
Munich, Germany, 81377
Contact: Dirk Sibbing, MD       Dirk.Sibbing@med.uni-muenchen.de   
Contact: Kristin Waldecker       Kristin.Waldecker@med.uni-muenchen.de   
Principal Investigator: Dirk Sibbing, MD         
Principal Investigator: Julinda Mehilli, MD         
Sub-Investigator: Lisa Gross, MD         
Universitätsmedizin Rostock, Zentrum für Innere Medizin Recruiting
Rostock, Germany, 18057
Contact: Christoph Nienaber, MD       Christoph.nienaber@med.uni-rostock.de   
Principal Investigator: Christoph Nienaber, MD         
University Hospital of Tuebingen, Department of Cardiology Recruiting
Tuebingen, Germany, 72076
Contact: Tobias Geisler, MD       tobias.geisler@med.uni-tuebingen.de   
Principal Investigator: Tobias Geisler, MD         
Kliniken Nordoberpfalz AG, Klinikum Weiden, Medizinische Klinik II Recruiting
Weiden, Germany, 92637
Contact: Robert Schwinger, MD       Robert.Schwinger@Kliniken-Nordoberpfalz.ag   
Principal Investigator: Robert Schwinger, MD         
Hungary
Budapest Military Hospital Recruiting
Budapest, Hungary, 1134
Contact: Róbert Gábor Kiss, MD       robertgaborkiss@gmail.com   
Principal Investigator: Róbert Gábor Kiss, MD         
Heart Center Balatonfüred Recruiting
Budapest, Hungary, 8230
Contact: Daniel Aradi, MD       daniel_aradi@yahoo.com   
Principal Investigator: Daniel Aradi, MD         
Semmelweis Egyetem Kardiovaszkuláris Centrum Recruiting
Budapest, Hungary, 1122
Contact: Béla Merkely, MD       merkely.bela@kardio.sote.hu   
Principal Investigator: Béla Merkely, MD         
PTE KK Szívgyógyászati Klinika Intervenciós Kardiológia Részleg Recruiting
Pecs, Hungary, 7624
Contact: András Komócsi, MD       andras.komocsi@aok.pte.hu   
Principal Investigator: András Komócsi, MD         
Sponsors and Collaborators
Klinikum der Universitaet Muenchen
Investigators
Principal Investigator: Dirk Sibbing, MD Munich University Hospital
Principal Investigator: Julinda Mehilli, MD Munich University Hospital
Study Chair: Steffen Massberg, MD Munich University Hospital
  More Information

No publications provided

Responsible Party: Klinikum der Universitaet Muenchen
ClinicalTrials.gov Identifier: NCT01959451     History of Changes
Other Study ID Numbers: MucT001-13
Study First Received: October 8, 2013
Last Updated: March 26, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Klinikum der Universitaet Muenchen:
Prasugrel
Clopidogrel

Additional relevant MeSH terms:
Angina Pectoris
Acute Coronary Syndrome
Cardiovascular Diseases
Chest Pain
Heart Diseases
Myocardial Ischemia
Pain
Signs and Symptoms
Vascular Diseases
Clopidogrel
Prasugrel
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Purinergic Agents
Purinergic Antagonists
Purinergic P2 Receptor Antagonists
Purinergic P2Y Receptor Antagonists
Therapeutic Uses

ClinicalTrials.gov processed this record on March 30, 2015