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 2014 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 28, 2014
Last verified: March 2014
  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 5160 ext 2266 dirk.sibbing@med.uni-muenchen.de
Contact: Julinda Mehilli, MD +49 89 7095 ext 3053 julinda.mehilli@med.uni-muenchen.de

Locations
Germany
Heart Center Bad Krozingen Recruiting
Bad Krozingen, Germany, 79189
Contact: Franz-Josef Neumann, MD       franz-josef.neumann@universitaets-herzzentrum.de   
Contact: Dietmar Trenk, MD       Dietmar.Trenk@universitaets-herzzentrum.de   
Principal Investigator: Franz-Josef Neumann, MD         
Sub-Investigator: Dieter Trenk         
St. Josef Hospital im Katholischen Klinikum Bochum Department of Cardiology Recruiting
Bochum, Germany, 44791
Contact: Andreas Mügge, MD       a.muegge@klinikum-bochum.de   
Contact: Kara Kaffer, MD       k.kara@klinikum-bochum.de   
Principal Investigator: Andreas Mügge, MD         
Sub-Investigator: Kara Kaffer, MD         
Heart Center at the University Medical Center Goettingen Not yet recruiting
Goettingen, Germany, 37075
Contact: Claudius Jacobshagen, MD       jacobshagen@med.uni-goettingen.de   
Principal Investigator: Claudius Jacobshagen, MD         
University Hospital Mainz, Department of Cardiology Recruiting
Mainz, Germany, 55131
Contact: Tomasso Gori, MD       Tommaso.Gori@unimedizin-mainz.de   
Principal Investigator: Tommaso Gori, MD         
Munich University Clinic, Campus Innenstadt Recruiting
Munich, Germany, 80336
Contact: Dirk Sibbing, MD    +49 89 5160 ext 2266    dirk.sibbing@med.uni-muenchen.de   
Contact: Monika Baylacher    +49 89 5160 ext 7670    Monika.Baylacher@med.uni-muenchen.de   
Principal Investigator: Dirk Sibbing, MD         
Munich University Clinic, Campus Grosshadern Recruiting
Munich, Germany, 81337
Contact: Julinda Mehilli, MD    +49 89 7095 ext 3053    julinda.mehilli@med.uni-muenchen.de   
Contact: Martina Schulz    +49 89 7095 ext 3064    martina.schulz@med.uni-muenchen.de   
Principal Investigator: Julinda Mehilli, MD         
Sub-Investigator: Martin Orban, MD         
Klinikum Bogenhausen Recruiting
Munich, Germany, 81925
Contact: Johannes Rieber, MD       Johannes.Rieber@klinikum-muenchen.de   
Principal Investigator: Johannes Rieber, MD         
University Clinic of Tuebingen, Department of Cardiology and Cardiovascular Medicine Recruiting
Tuebingen, Germany, 72076
Contact: Tobias Geisler, MD       tobias.geisler@med.uni-tuebingen.de   
Principal Investigator: Tobias Geisler, MD         
Hungary
Heart Center Balatonfüred Recruiting
Budapest, Hungary, 8230
Contact: Daniel Aradi, MD    +36302355639    daniel_aradi@yahoo.com   
Principal Investigator: Daniel Aradi, MD         
Sponsors and Collaborators
Klinikum der Universitaet Muenchen
Investigators
Principal Investigator: Dirk Sibbing, MD Munich University Clinic, Campus Innenstadt
Principal Investigator: Julinda Mehilli, MD Munich University Clinic, Campus Grosshadern
Study Chair: Steffen Massberg, MD Munich University Clinic, Campus Grosshadern and Innenstadt
  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 28, 2014
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
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Clopidogrel
Prasugrel
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 30, 2014