TIcagrelor in Rotational Atherectomy to Reduce TROPonin Enhancement (TIRATROP)
May 28, 2026 updated by: University Hospital, Toulouse
TIcagrelor in Rotational Atherectomy to Reduce TROPonin Enhancement: the TIRATROP Study, a Randomized Controlled Trial
Rotational atherectomy (RA) prior to angioplasty is the reference treatment for highly calcified atherosclerotic coronary lesions.
It aims at fragmenting calcium deposits into microscopic particulates to allow less hazardous coronary revascularization and stenting.
The main drawback associated with the procedure is the subsequent enhancement of platelet aggregation which promotes the distal embolization of micro-thrombi and atherosclerotic fragments.
In order to limit these complications, a double antiplatelet therapy is required (generally Clopidogrel + Aspirin) when RA procedures are performed.
Clopidogrel inhibits the protein P2Y12 which is a cornerstone in platelet aggregation.
Ticagrelor is a new antiplatelet agent that provides faster and greater P2Y12 inhibition than Clopidogrel.
It is currently indicated to reduce risk of cardiovascular events in patients hospitalized for coronary revascularization after an acute coronary syndrome.
Ticagrelor has never been evaluated so far in stable coronary patients treated with rotational atherectomy prior to angioplasty.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Rotational atherectomy (RA) prior to angioplasty is the reference treatment for highly calcified atherosclerotic coronary lesions.
It aims at fragmenting calcium deposits into microscopic particulates to allow less hazardous coronary revascularization and stenting.
The main drawback associated with the procedure is the subsequent enhancement of platelet aggregation which promotes the distal embolization of micro-thrombi and atherosclerotic fragments.
In order to limit these complications, a double antiplatelet therapy is required (generally Clopidogrel + Aspirin) when RA procedures are performed.
Clopidogrel inhibits the protein P2Y12 which is a cornerstone in platelet aggregation.
It is characterized by a slow and variable transformation of a prodrug into an active metabolite and by a remaining risk of thrombosis and myocardial infarction.
Ticagrelor is a new antiplatelet agent that provides faster and greater P2Y12 inhibition than Clopidogrel.
It is currently indicated to reduce risk of cardiovascular events in patients hospitalized for coronary revascularization after an acute coronary syndrome.
Ticagrelor has never been evaluated so far in stable coronary patients treated with rotational atherectomy prior to angioplasty.
Study Type
Interventional
Enrollment (Actual)
180
Phase
- 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
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Lyon, France, 69000
- Hospices Civils de Lyon
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Nîmes, France, 30000
- University Hospital
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Haute-Garonne
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Toulouse, Haute-Garonne, France, 31000
- Clinique Pasteur
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Toulouse, Haute-Garonne, France, 31059
- Fédération de Cardiologie CHU TOULOUSE
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-
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
Ages Eligible for Study
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion criteria :
- Stable coronary patient, or patient presenting with a non ST-elevation acute coronary syndrome without troponin elevation, or with troponin back to normal,
- Patient treated with a combination of Aspirin + Clopidogrel before hospitalization at the study center,
- Patient with at least one highly calcified coronary lesion eligible for rotational atherectomy prior to angioplasty,
- Patient agreed to participate after full information on the study.
Exclusion criteria :
- Acute coronary syndrome with ST-elevation,
- Plasma troponin level higher than 3 times the upper limit of the laboratory,
- Lesion located on a coronary bypass,
- Coronary thrombus diagnosed by angiography,
- Coronary dissection diagnosed by angiography,
- Left ventricular ejection fraction lower than 30%,
Contra-indication to use Ticagrelor or Clopidogrel as listed in the Summary of Product Characteristics (SmPC, annex 1 & 2):
- Known hypersensitivity to the active substance or to the excipients,
- Active pathological bleeding,
- History of intracranial hemorrhage,
- Moderate to severe hepatic impairment,
- Co-administration with a strong cytochrome P450 3A4 inhibitor (e.g. ketoconazole, clarithromycin, nefazodone, ritonavir, and atazanavir),
Other conditions at increased risk of bleeding:
- Congenital or acquired coagulation disorder
- Gastroduodenal bleeding within past 6 months,
- Recent major trauma or surgery within past 30 days,
- Concomitant use of fibrinolytics, oral anticoagulation, non-steroidal antiinflammatory drugs,
- Significant anemia,
- Increased risk of bradycardia,
- History of asthma or Chronic Obstructive Pulmonary Disease,
- Uric acid nephropathy,
- Ischemic stroke within 7 days,
- Heredity galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption,
- Concomitant use of a strong CYP3A4 inducer
- Concomitant use of CYP3A4 substrates with narrow therapeutic indices (e.g. cisapride, ergot alkaloids), simvastatin at a dose greater than 40 mg/d,
- Concomitant use of Selective Serotonin Reuptake inhibitors,
- Concomitant use of digoxin without close clinical and laboratory monitoring,
- Contra-indication to use Aspirin,
- Breast-feeding,
- Pregnancy,
- Adult protected by the law,
- Patient participating in another biomedical research.
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ticagrelor
In the intervention group, Ticagrelor will be administered orally, according to the following scheme:
|
Ticagrelor will be administered orally, according to the following scheme:
Other Names:
|
|
Active Comparator: clopidogrel
In the control group, Clopidogrel will be administered orally, according to the following scheme:
|
Clopidogrel will be administered orally, according to the following scheme:
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
area under the curve corresponding to troponin level as a function of time
Time Frame: up to 24 hours
|
Troponin kinetics during the first 24 hours following rotational atherectomy.
|
up to 24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
area under the curve corresponding to troponin level as a function of time
Time Frame: up to 36 hours
|
up to 36 hours
|
|
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Frequence of clinical events during the in-hospital period
Time Frame: One day before the procedure until 36 hours after.
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One day before the procedure until 36 hours after.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Didier Didier, PHD, University Hospital, Toulouse
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.
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
November 1, 2015
Primary Completion (Actual)
May 24, 2018
Study Completion (Actual)
May 30, 2018
Study Registration Dates
First Submitted
June 3, 2015
First Submitted That Met QC Criteria
July 21, 2015
First Posted (Estimated)
July 22, 2015
Study Record Updates
Last Update Posted (Actual)
June 1, 2026
Last Update Submitted That Met QC Criteria
May 28, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Vascular Diseases
- Cardiovascular Diseases
- Embolism and Thrombosis
- Arteriosclerosis
- Arterial Occlusive Diseases
- Thrombosis
- Atherosclerosis
- Sulfur Compounds
- Organic Chemicals
- Pyridines
- Heterocyclic Compounds, 1-Ring
- Heterocyclic Compounds
- Heterocyclic Compounds, 2-Ring
- Heterocyclic Compounds, Fused-Ring
- Nucleic Acids, Nucleotides, and Nucleosides
- Purines
- Nucleosides
- Ribonucleosides
- Thiophenes
- Adenosine
- Purine Nucleosides
- Ticlopidine
- Thienopyridines
- Ticagrelor
- Clopidogrel
Other Study ID Numbers
- RC31/14/7445
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