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Acute Coronary SyndromePhase 4TROPICAL-ACSNCT01959451

Testing Responsiveness to Platelet Inhibition on Chronic Antiplatelet Treatment For Acute Coronary Syndromes Trial

A Phase 4 study testing Prasugrel and Clopidogrel in people with Acute Coronary Syndrome, run by LMU Klinikum at 33 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Acute Coronary Syndrome
What is being tested?
Prasugrel and Clopidogrel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,600 participants
Where
33 sitesin 4 countries
Study dates
Sep 2013to Jun 2017
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

33 sites in 4 countries.

33 sites in 4 countries

Germany20 sites

  • Klinikum Augsburg, Department of Cardiology

    Augsburg, 86156

  • Heart Center Bad Krozingen

    Bad Krozingen, 79189

  • Asklepios Stadtklinik Bad Tölz, Internal Medicine

    Bad Tölz, 83646

  • St. Josef Hospital, Katholisches Klinikum Bochum, Department of Cardiology

    Bochum, 44791

  • Herzzentrum der Universität zu Köln

    Cologne, 50937

  • Universitätsklinikum Frankfurt, Department of Cardiology

    Frankfurt, 60590

  • Kliniken Ostallgäu-Kaufbeuren, Klinik Füssen

    Füssen, 87629

  • Heart Center at the University Medical Center Goettingen

    Göttingen, 37075

  • Universitätsmedizin Greifswald, Klinik u. Poliklinik für Innere Medizin B

    Greifswald, 17475

  • Universitäres Herzzentrum Hamburg, UKE

    Hamburg, 20246

  • University Hospital Mainz, Department of Cardiology

    Mainz, 55131

  • Klinikum Memmingen, Innere Medizin I

    Memmingen, 87700

  • Munich University Hospital

    Munich, 81377

  • Klinikum Neuperlach, Department of Cardiology

    Munich, 81737

  • Klinikum Bogenhausen, Department of Cardiology

    Munich, 81925

  • Klinikum Oldenburg gGmbH, Herz-Kreislauf-Zentrum, Klinik für Kardiologie

    Oldenburg, 26133

  • Universitätsmedizin Rostock, Zentrum für Innere Medizin

    Rostock, 18057

  • Helios-Klinikum Siegburg, Abteilung für Kardiologie und Angiologie

    Siegburg, 53721

  • University Hospital of Tuebingen, Department of Cardiology

    Tübingen, 72076

  • Kliniken Nordoberpfalz AG, Klinikum Weiden, Medizinische Klinik II

    Weiden, 92637

Other trials in Germany

Hungary7 sites

  • Semmelweis Egyetem Kardiovaszkuláris Centrum

    Budapest, 1122

  • Budapest Military Hospital

    Budapest, 1134

  • Heart Center Balatonfüred

    Budapest, 8230

  • Department of Cardiology Petz Aladár Megyei Oktató Kórház

    Győr, 9023

  • Heart Center Kecskemet

    Kecskemét, 6000

  • PTE KK Szívgyógyászati Klinika Intervenciós Kardiológia Részleg

    Pécs, 7624

  • Heart Center Szeged

    Szeged, 6720

Other trials in Hungary

Poland4 sites

  • 3rd Department of Cardiology, Upper Silesian Medical Centre, Medical University of Silesia, Katowice

    Katowice, 40635

  • 1st Department of Cardiology, Poznan University of Medical Science

    Poznan, 61848

  • 1st Department of Cardiology, Medical University of Warsaw

    Warsaw, 2097

  • Department of Interventional Cardiology and Angiology, Institute of Cardiology, Warsaw

    Warsaw, 2795

Other trials in Poland

Austria2 sites

  • Medizin-Universität Graz, Univ. Klinik für Innere Medizin

    Graz, 8036

  • Wilhelminenspital Wien, 3. Medizinische Abteilung

    Vienna, 1160

Other trials in Austria

About this study

Official title: 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).

Read the 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.

Being tested
Prasugrel, Clopidogrel
Keywords
Prasugrel, Clopidogrel
Medical subject headings
Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PrasugrelDrug

    Also called Efient

    see Arm description

  • ClopidogrelDrug

    Also called Iscover, Plavix

    see arm description

Study groups in NCT01959451
Study groupRoleWhat they receive
PrasugrelActive comparatorPrasugrel 5 mg or 10mg daily for 12 months.
Receives: Drug: Prasugrel
Prasugrel/ClopidogrelExperimentalDay 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
Receives: Drug: Clopidogrel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite of death from cardiovascular cause, myocardial infarction, stroke and bleeding grade ≥ 2 defined according to BARC criteria

    Measured: 12 months

Secondary outcomes (3)

  1. bleeding events BARC class ≥2

    Measured: 12 months

  2. stent thrombosis

    Measured: 12 months

  3. all-cause death

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2013 (estimated)
  2. Study startSep 2013
  3. Primary completionMay 2016
  4. Study completionJun 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,600 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01959451
Sponsor's protocol ID
MucT001-13
Acronym
TROPICAL-ACS
Status last verified
Feb 2019
First submitted
8 Oct 2013
Last updated
1 Mar 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Sibbing D, Aradi D, Jacobshagen C, Gross L, Trenk D, Geisler T, Orban M, Hadamitzky M, Merkely B, Kiss RG, Komocsi A, Dezsi 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.

    PubMed 28855078

  • Sibbing D, Aradi D, Jacobshagen C, Gross L, Trenk D, Geisler T, Orban M, Gori T, Hadamitzky M, Merkely B, Kiss RG, Komocsi A, Dezsi CA, Thalmeier A, Low A, Holdt L, Teupser D, Ince H, Felix SB, Parma R, Malek L, Horstkotte J, Baylacher M, Schwinger R, Rieber J, Mudra H, Hausleiter J, Huber K, Neumann FJ, Koltowski L, Huczek Z, Mehilli J, Massberg S; TROPICAL-ACS Investigators. A randomised trial on platelet function-guided de-escalation of antiplatelet treatment in ACS patients undergoing PCI. Rationale and design of the Testing Responsiveness to Platelet Inhibition on Chronic Antiplatelet Treatment for Acute Coronary Syndromes (TROPICAL-ACS) Trial. Thromb Haemost. 2017 Jan 5;117(1):188-195. doi: 10.1160/TH16-07-0557. Epub 2016 Sep 22.

    PubMed 27652610

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Prasugrel and Clopidogrel in people with Acute Coronary Syndrome, run by LMU Klinikum at 33 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in Germany, Hungary, Poland, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01959451, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2019.

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