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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Dirk Sibbing, Klinikum der Universitaet Muenchen
ClinicalTrials.gov Identifier:
NCT01959451
First received: October 8, 2013
Last updated: May 27, 2016
Last verified: May 2016
  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 ]

Enrollment: 2600
Study Start Date: September 2013
Estimated Study Completion Date: May 2017
Primary Completion Date: May 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   (Adult, Senior)
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

Locations
Austria
Medizin-Universität Graz, Univ. Klinik für Innere Medizin
Graz, Austria, 8036
Wilhelminenspital Wien, 3. Medizinische Abteilung
Vienna, Austria, 1160
Germany
Klinikum Augsburg, Department of Cardiology
Augsburg, Germany, 86156
Heart Center Bad Krozingen
Bad Krozingen, Germany, 79189
Asklepios Stadtklinik Bad Tölz, Internal Medicine
Bad Tölz, Germany, 83646
St. Josef Hospital, Katholisches Klinikum Bochum, Department of Cardiology
Bochum, Germany, 44791
Universitätsklinikum Frankfurt, Department of Cardiology
Frankfurt, Germany, 60590
Kliniken Ostallgäu-Kaufbeuren, Klinik Füssen
Füssen, Germany, 87629
Heart Center at the University Medical Center Goettingen
Goettingen, Germany, 37075
Universitätsmedizin Greifswald, Klinik u. Poliklinik für Innere Medizin B
Greifswald, Germany, 17475
Universitäres Herzzentrum Hamburg, UKE
Hamburg, Germany, 20246
Herzzentrum der Universität zu Köln
Köln, Germany, 50937
University Hospital Mainz, Department of Cardiology
Mainz, Germany, 55131
Klinikum Memmingen, Innere Medizin I
Memmingen, Germany, 87700
Munich University Hospital
Munich, Germany, 81377
Klinikum Neuperlach, Department of Cardiology
Munich, Germany, 81737
Klinikum Bogenhausen, Department of Cardiology
Munich, Germany, 81925
Klinikum Oldenburg gGmbH, Herz-Kreislauf-Zentrum, Klinik für Kardiologie
Oldenburg, Germany, 26133
Universitätsmedizin Rostock, Zentrum für Innere Medizin
Rostock, Germany, 18057
Helios-Klinikum Siegburg, Abteilung für Kardiologie und Angiologie
Siegburg, Germany, 53721
University Hospital of Tuebingen, Department of Cardiology
Tuebingen, Germany, 72076
Kliniken Nordoberpfalz AG, Klinikum Weiden, Medizinische Klinik II
Weiden, Germany, 92637
Hungary
Semmelweis Egyetem Kardiovaszkuláris Centrum
Budapest, Hungary, 1122
Budapest Military Hospital
Budapest, Hungary, 1134
Heart Center Balatonfüred
Budapest, Hungary, 8230
Department of Cardiology Petz Aladár Megyei Oktató Kórház
Györ, Hungary, 9023
Heart Center Kecskemet
Kecskemet, Hungary, 6000
PTE KK Szívgyógyászati Klinika Intervenciós Kardiológia Részleg
Pecs, Hungary, 7624
Heart Center Szeged
Szeged, Hungary, 6720
Poland
3rd Department of Cardiology, Upper Silesian Medical Centre, Medical University of Silesia, Katowice
Katowice, Poland, 40635
1st Department of Cardiology, Poznan University of Medical Science
Poznan, Poland, 61848
1st Department of Cardiology, Medical University of Warsaw
Warsaw, Poland, 2097
Department of Interventional Cardiology and Angiology, Institute of Cardiology, Warsaw
Warsaw, Poland, 2795
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

Responsible Party: Dirk Sibbing, Prof. Dr. Dirk Sibbing, 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: May 27, 2016
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Klinikum der Universitaet Muenchen:
Prasugrel
Clopidogrel

Additional relevant MeSH terms:
Syndrome
Acute Coronary Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Clopidogrel
Ticlopidine
Prasugrel Hydrochloride
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 25, 2016