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

February 28, 2019 updated by: Dirk Sibbing, LMU Klinikum

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2600

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: Prasugrel
Prasugrel 5 mg or 10mg daily for 12 months.
Drug: Prasugrel
see Arm description
Other Names:
  • 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:
  • Plavix
  • Iscover

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Composite of death from cardiovascular cause, myocardial infarction, stroke and bleeding grade ≥ 2 defined according to BARC criteria
Time Frame: 12 months
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
all-cause death
Time Frame: 12 months
12 months
bleeding events BARC class ≥2
Time Frame: 12 months
12 months
stent thrombosis
Time Frame: 12 months
12 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
economic impact of a platelet function testing guided tailored treatment for ACS patients
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
LMU Klinikum

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dirk Sibbing, MD, Munich University Hospital
  • Principal Investigator: Julinda Mehilli, MD, Munich University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2013

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 8, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 8, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 10, 2013

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 1, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MucT001-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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