Back to resultsTesting Responsiveness to Platelet Inhibition on Chronic Antiplatelet Treatment For Acute Coronary Syndromes Trial (TROPICAL-ACS)
Primary Purpose
Acute Coronary Syndrome
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Prasugrel
Clopidogrel
Sponsored by
About this trial
This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring Prasugrel, Clopidogrel
Eligibility Criteria
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
Sites / Locations
- Medizin-Universität Graz, Univ. Klinik für Innere Medizin
- Wilhelminenspital Wien, 3. Medizinische Abteilung
- Klinikum Augsburg, Department of Cardiology
- Heart Center Bad Krozingen
- Asklepios Stadtklinik Bad Tölz, Internal Medicine
- St. Josef Hospital, Katholisches Klinikum Bochum, Department of Cardiology
- Universitätsklinikum Frankfurt, Department of Cardiology
- Kliniken Ostallgäu-Kaufbeuren, Klinik Füssen
- Universitätsmedizin Greifswald, Klinik u. Poliklinik für Innere Medizin B
- Heart Center at the University Medical Center Goettingen
- Universitäres Herzzentrum Hamburg, UKE
- Herzzentrum der Universität zu Köln
- University Hospital Mainz, Department of Cardiology
- Klinikum Memmingen, Innere Medizin I
- Munich University Hospital
- Klinikum Neuperlach, Department of Cardiology
- Klinikum Bogenhausen, Department of Cardiology
- Klinikum Oldenburg gGmbH, Herz-Kreislauf-Zentrum, Klinik für Kardiologie
- Universitätsmedizin Rostock, Zentrum für Innere Medizin
- Helios-Klinikum Siegburg, Abteilung für Kardiologie und Angiologie
- University Hospital of Tuebingen, Department of Cardiology
- Kliniken Nordoberpfalz AG, Klinikum Weiden, Medizinische Klinik II
- Semmelweis Egyetem Kardiovaszkuláris Centrum
- Budapest Military Hospital
- Heart Center Balatonfüred
- Department of Cardiology Petz Aladár Megyei Oktató Kórház
- Heart Center Kecskemet
- PTE KK Szívgyógyászati Klinika Intervenciós Kardiológia Részleg
- Heart Center Szeged
- 3rd Department of Cardiology, Upper Silesian Medical Centre, Medical University of Silesia, Katowice
- 1st Department of Cardiology, Poznan University of Medical Science
- 1st Department of Cardiology, Medical University of Warsaw
- Department of Interventional Cardiology and Angiology, Institute of Cardiology, Warsaw
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Prasugrel
Prasugrel/Clopidogrel
Arm Description
Prasugrel 5 mg or 10mg daily for 12 months.
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
Outcomes
Primary Outcome Measures
Composite of death from cardiovascular cause, myocardial infarction, stroke and bleeding grade ≥ 2 defined according to BARC criteria
Secondary Outcome Measures
bleeding events BARC class ≥2
stent thrombosis
all-cause death
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01959451
Brief Title
Testing Responsiveness to Platelet Inhibition on Chronic Antiplatelet Treatment For Acute Coronary Syndromes Trial
Acronym
TROPICAL-ACS
Official Title
Platelet Function Guided Prasugrel Therapy in ACS Patients Undergoing PCI
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
June 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
LMU Klinikum
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
Keywords
Prasugrel, Clopidogrel
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2600 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prasugrel
Arm Type
Active Comparator
Arm Description
Prasugrel 5 mg or 10mg daily for 12 months.
Arm Title
Prasugrel/Clopidogrel
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Prasugrel
Other Intervention Name(s)
Efient
Intervention Description
see Arm description
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Other Intervention Name(s)
Iscover, Plavix
Intervention Description
see arm description
Primary Outcome Measure Information:
Title
Composite of death from cardiovascular cause, myocardial infarction, stroke and bleeding grade ≥ 2 defined according to BARC criteria
Time Frame
12 months
Secondary Outcome Measure Information:
Title
bleeding events BARC class ≥2
Time Frame
12 months
Title
stent thrombosis
Time Frame
12 months
Title
all-cause death
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
economic impact of a platelet function testing guided tailored treatment for ACS patients
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dirk Sibbing, MD
Organizational Affiliation
Munich University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Julinda Mehilli, MD
Organizational Affiliation
Munich University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Steffen Massberg, MD
Organizational Affiliation
Munich University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Medizin-Universität Graz, Univ. Klinik für Innere Medizin
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Wilhelminenspital Wien, 3. Medizinische Abteilung
City
Vienna
ZIP/Postal Code
1160
Country
Austria
Facility Name
Klinikum Augsburg, Department of Cardiology
City
Augsburg
ZIP/Postal Code
86156
Country
Germany
Facility Name
Heart Center Bad Krozingen
City
Bad Krozingen
ZIP/Postal Code
79189
Country
Germany
Facility Name
Asklepios Stadtklinik Bad Tölz, Internal Medicine
City
Bad Tölz
ZIP/Postal Code
83646
Country
Germany
Facility Name
St. Josef Hospital, Katholisches Klinikum Bochum, Department of Cardiology
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Facility Name
Universitätsklinikum Frankfurt, Department of Cardiology
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Kliniken Ostallgäu-Kaufbeuren, Klinik Füssen
City
Füssen
ZIP/Postal Code
87629
Country
Germany
Facility Name
Universitätsmedizin Greifswald, Klinik u. Poliklinik für Innere Medizin B
City
Greifswald
ZIP/Postal Code
17475
Country
Germany
Facility Name
Heart Center at the University Medical Center Goettingen
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Universitäres Herzzentrum Hamburg, UKE
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Herzzentrum der Universität zu Köln
City
Köln
ZIP/Postal Code
50937
Country
Germany
Facility Name
University Hospital Mainz, Department of Cardiology
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Klinikum Memmingen, Innere Medizin I
City
Memmingen
ZIP/Postal Code
87700
Country
Germany
Facility Name
Munich University Hospital
City
Munich
ZIP/Postal Code
81377
Country
Germany
Facility Name
Klinikum Neuperlach, Department of Cardiology
City
Munich
ZIP/Postal Code
81737
Country
Germany
Facility Name
Klinikum Bogenhausen, Department of Cardiology
City
Munich
ZIP/Postal Code
81925
Country
Germany
Facility Name
Klinikum Oldenburg gGmbH, Herz-Kreislauf-Zentrum, Klinik für Kardiologie
City
Oldenburg
ZIP/Postal Code
26133
Country
Germany
Facility Name
Universitätsmedizin Rostock, Zentrum für Innere Medizin
City
Rostock
ZIP/Postal Code
18057
Country
Germany
Facility Name
Helios-Klinikum Siegburg, Abteilung für Kardiologie und Angiologie
City
Siegburg
ZIP/Postal Code
53721
Country
Germany
Facility Name
University Hospital of Tuebingen, Department of Cardiology
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Kliniken Nordoberpfalz AG, Klinikum Weiden, Medizinische Klinik II
City
Weiden
ZIP/Postal Code
92637
Country
Germany
Facility Name
Semmelweis Egyetem Kardiovaszkuláris Centrum
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Budapest Military Hospital
City
Budapest
ZIP/Postal Code
1134
Country
Hungary
Facility Name
Heart Center Balatonfüred
City
Budapest
ZIP/Postal Code
8230
Country
Hungary
Facility Name
Department of Cardiology Petz Aladár Megyei Oktató Kórház
City
Györ
ZIP/Postal Code
9023
Country
Hungary
Facility Name
Heart Center Kecskemet
City
Kecskemet
ZIP/Postal Code
6000
Country
Hungary
Facility Name
PTE KK Szívgyógyászati Klinika Intervenciós Kardiológia Részleg
City
Pecs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
Heart Center Szeged
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
3rd Department of Cardiology, Upper Silesian Medical Centre, Medical University of Silesia, Katowice
City
Katowice
ZIP/Postal Code
40635
Country
Poland
Facility Name
1st Department of Cardiology, Poznan University of Medical Science
City
Poznan
ZIP/Postal Code
61848
Country
Poland
Facility Name
1st Department of Cardiology, Medical University of Warsaw
City
Warsaw
ZIP/Postal Code
2097
Country
Poland
Facility Name
Department of Interventional Cardiology and Angiology, Institute of Cardiology, Warsaw
City
Warsaw
ZIP/Postal Code
2795
Country
Poland
12. IPD Sharing Statement
Citations:
PubMed Identifier
28855078
Citation
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.
Results Reference
derived
PubMed Identifier
27652610
Citation
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.
Results Reference
derived
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/27652610
Description
Rationale and design of the Testing Responsiveness to Platelet Inhibition on Chronic Antiplatelet Treatment for Acute Coronary Syndromes (TROPICAL-ACS) Trial
Learn more about this trial
Testing Responsiveness to Platelet Inhibition on Chronic Antiplatelet Treatment For Acute Coronary Syndromes Trial
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