Brief 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 treatment with prasugrel in acute coronary syndrome (ACS) patients treated with percutaneous coronary intervention (PCI).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

2,600

participants targeted

Target at P75+ for phase_4

Timeline

Completed

Started Sep 2013

Longer than P75 for phase_4

Geographic Reach

4 countries

33 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.8 years study duration

Study Start

First participant enrolled

September 1, 2013

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

October 8, 2013

Completed

2 days until next milestone

First Posted

Study publicly available on registry

October 10, 2013

Completed

2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed

1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed

Last Updated

March 1, 2019

Status Verified

February 1, 2019

Enrollment Period

2.7 years

First QC Date

October 8, 2013

Last Update Submit

February 28, 2019

Conditions

Acute Coronary Syndrome

Keywords

PrasugrelClopidogrel

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (3)

bleeding events BARC class ≥2
12 months
stent thrombosis
12 months
all-cause death
12 months

Other Outcomes (1)

economic impact of a platelet function testing guided tailored treatment for ACS patients
12 months

Study Arms (2)

Prasugrel

ACTIVE COMPARATOR

Prasugrel 5 mg or 10mg daily for 12 months.

Drug: Prasugrel

Prasugrel/Clopidogrel

EXPERIMENTAL

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

Interventions

PrasugrelDRUG

see Arm description

Also known as: Efient

Prasugrel

ClopidogrelDRUG

see arm description

Also known as: Iscover, Plavix

Prasugrel/Clopidogrel

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

LMU Klinikumlead

Study Sites (33)

Medizin-Universität Graz, Univ. Klinik für Innere Medizin

Graz, 8036, Austria

Location

Wilhelminenspital Wien, 3. Medizinische Abteilung

Vienna, 1160, Austria

Location

Klinikum Augsburg, Department of Cardiology

Augsburg, 86156, Germany

Location

Heart Center Bad Krozingen

Bad Krozingen, 79189, Germany

Location

Asklepios Stadtklinik Bad Tölz, Internal Medicine

Bad Tölz, 83646, Germany

Location

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

Bochum, 44791, Germany

Location

Herzzentrum der Universität zu Köln

Cologne, 50937, Germany

Location

Universitätsklinikum Frankfurt, Department of Cardiology

Frankfurt, 60590, Germany

Location

Kliniken Ostallgäu-Kaufbeuren, Klinik Füssen

Füssen, 87629, Germany

Location

Heart Center at the University Medical Center Goettingen

Göttingen, 37075, Germany

Location

Universitätsmedizin Greifswald, Klinik u. Poliklinik für Innere Medizin B

Greifswald, 17475, Germany

Location

Universitäres Herzzentrum Hamburg, UKE

Hamburg, 20246, Germany

Location

University Hospital Mainz, Department of Cardiology

Mainz, 55131, Germany

Location

Klinikum Memmingen, Innere Medizin I

Memmingen, 87700, Germany

Location

Munich University Hospital

Munich, 81377, Germany

Location

Klinikum Neuperlach, Department of Cardiology

Munich, 81737, Germany

Location

Klinikum Bogenhausen, Department of Cardiology

Munich, 81925, Germany

Location

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

Oldenburg, 26133, Germany

Location

Universitätsmedizin Rostock, Zentrum für Innere Medizin

Rostock, 18057, Germany

Location

Helios-Klinikum Siegburg, Abteilung für Kardiologie und Angiologie

Siegburg, 53721, Germany

Location

University Hospital of Tuebingen, Department of Cardiology

Tübingen, 72076, Germany

Location

Kliniken Nordoberpfalz AG, Klinikum Weiden, Medizinische Klinik II

Weiden, 92637, Germany

Location

Semmelweis Egyetem Kardiovaszkuláris Centrum

Budapest, 1122, Hungary

Location

Budapest Military Hospital

Budapest, 1134, Hungary

Location

Heart Center Balatonfüred

Budapest, 8230, Hungary

Location

Department of Cardiology Petz Aladár Megyei Oktató Kórház

Győr, 9023, Hungary

Location

Heart Center Kecskemet

Kecskemét, 6000, Hungary

Location

PTE KK Szívgyógyászati Klinika Intervenciós Kardiológia Részleg

Pécs, 7624, Hungary

Location

Heart Center Szeged

Szeged, 6720, Hungary

Location

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

Katowice, 40635, Poland

Location

1st Department of Cardiology, Poznan University of Medical Science

Poznan, 61848, Poland

Location

1st Department of Cardiology, Medical University of Warsaw

Warsaw, 2097, Poland

Location

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

Warsaw, 2795, Poland

Location

Related Publications (2)

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.
PMID: 28855078DERIVED
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.
PMID: 27652610DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Prasugrel HydrochlorideClopidogrel

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTiclopidineThienopyridinesPyridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

Dirk Sibbing, MD
Munich University Hospital
PRINCIPAL INVESTIGATOR
Julinda Mehilli, MD
Munich University Hospital
PRINCIPAL INVESTIGATOR
Steffen Massberg, MD
Munich University Hospital
STUDY CHAIR

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Prof. Dr. Dirk Sibbing

Study Record Dates

First Submitted

October 8, 2013

First Posted

October 10, 2013

Study Start

September 1, 2013

Primary Completion

May 1, 2016

Study Completion

June 1, 2017

Last Updated

March 1, 2019

Record last verified: 2019-02

Locations

DE(20)AU(2)HU(7)PL(4)

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

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Other Outcomes (1)

Study Arms (2)

Prasugrel

Prasugrel/Clopidogrel

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (33)

Related Publications (2)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Other Outcomes (1)

Study Arms (2)

Prasugrel

Prasugrel/Clopidogrel

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (33)

Related Publications (2)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations