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

This study is currently recruiting participants.
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

October 8, 2013
March 28, 2014
September 2013
March 2016   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01959451 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
economic impact of a platelet function testing guided tailored treatment for ACS patients [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
 
Testing Responsiveness to Platelet Inhibition on Chronic Antiplatelet Treatment For Acute Coronary Syndromes Trial
Platelet Function Guided Prasugrel Therapy in ACS Patients Undergoing PCI

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).

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Coronary Syndrome
  • Drug: Prasugrel
    see Arm description
    Other Name: Efient
  • Drug: Clopidogrel
    see arm description
    Other Names:
    • Iscover
    • Plavix
  • Active Comparator: Prasugrel
    Prasugrel 5 mg or 10mg daily for 12 months.
    Intervention: Drug: Prasugrel
  • 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
    Intervention: Drug: Clopidogrel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2600
April 2016
March 2016   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
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
Germany,   Hungary
 
NCT01959451
MucT001-13
Yes
Klinikum der Universitaet Muenchen
Klinikum der Universitaet Muenchen
Not Provided
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
Klinikum der Universitaet Muenchen
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP