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

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ClinicalTrials.gov Identifier: NCT01959451
Recruitment Status : Completed
First Posted : October 10, 2013
Last Update Posted : June 29, 2017
Information provided by (Responsible Party):
Dirk Sibbing, Klinikum der Universitaet Muenchen

October 8, 2013
October 10, 2013
June 29, 2017
September 2013
May 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 ]
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 ]
  • stent thrombosis [ Time Frame: 12 months ]
  • all-cause death [ Time Frame: 12 months ]
Same as current
economic impact of a platelet function testing guided tailored treatment for ACS patients [ Time Frame: 12 months ]
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.
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Sibbing D, Aradi D, Jacobshagen C, Gross L, Trenk D, Geisler T, Orban M, Hadamitzky M, Merkely B, Kiss RG, Komócsi A, Dézsi 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
June 2017
May 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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Austria,   Germany,   Hungary,   Poland
Not Provided
Not Provided
Dirk Sibbing, Klinikum der Universitaet Muenchen
Klinikum der Universitaet Muenchen
Not Provided
Principal Investigator: Dirk Sibbing, MD Munich University Hospital
Principal Investigator: Julinda Mehilli, MD Munich University Hospital
Study Chair: Steffen Massberg, MD Munich University Hospital
Klinikum der Universitaet Muenchen
June 2017

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