AtherosclerosisPhase 4TIRATROPNCT02505399
TIcagrelor in Rotational Atherectomy to Reduce TROPonin Enhancement
A Phase 4 study testing ticagrelor and clopidogrel in people with Atherosclerosis, run by University Hospital, Toulouse at 4 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- ticagrelor and clopidogrel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 4 sitesFrance
- Study dates
- Nov 2015to 30 May 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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%,
Show all 32Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country.
France4 sites
Hospices civils de Lyon
Lyon, 69000
University Hospital
Nîmes, 30000
Clinique Pasteur
Toulouse, Haute-Garonne, 31000
Fédération de Cardiologie CHU TOULOUSE
Toulouse, Haute-Garonne, 31059
About this study
Official title: 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.
Read the 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.
- Conditions
- Atherosclerosis
- Being tested
- ticagrelor, clopidogrel
- Keywords
- Rotational Atherectomy, clopidogrel, thrombosis, ticagrelor
- Medical subject headings
- Atherosclerosis, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ticagrelorDrug
Also called ticagrelor per os
Ticagrelor will be administered orally, according to the following scheme:
- 180 mg the evening preceding (and at least 6 hours before) rotational atherectomy (Day -1),
- 90 mg the following morning (D Day before rotational atherectomy and angioplasty),
- 90 mg the following evening (D Day after rotational atherectomy and angioplasty),
- 90 mg twice daily the day after the procedure of rotational atherectomy and angioplasty (Day +1).
clopidogrelDrug
Also called clopidrogel per os
Clopidogrel will be administered orally, according to the following scheme:
- 300 mg the evening preceding (and at least 6 hours before) rotational atherectomy (Day -1),
- 75 mg the following morning (D Day before rotational atherectomy and angioplasty),
- 0 mg the following evening (D Day after rotational atherectomy and angioplasty),
- 75 mg once daily the day after the procedure of rotational atherectomy and angioplasty (Day +1).
| Study group | Role | What they receive |
|---|---|---|
| ticagrelor | Experimental | In the intervention group, Ticagrelor will be administered orally, according to the following scheme:
* 180 mg the evening preceding (and at least 6 hours before) rotational atherectomy (Day -1),
* 90 mg the following morning (D Day before rotational atherectomy and angioplasty),
* 90 mg the following evening (D Day after rotational atherectomy and angioplasty),
* 90 mg twice daily the day after the procedure of rotational atherectomy and angioplasty (Day +1). Receives: Drug: ticagrelor |
| clopidogrel | Active comparator | In the control group, Clopidogrel will be administered orally, according to the following scheme:
* 300 mg the evening preceding (and at least 6 hours before) rotational atherectomy (Day -1),
* 75 mg the following morning (D Day before rotational atherectomy and angioplasty),
* 0 mg the following evening (D Day after rotational atherectomy and angioplasty),
* 75 mg once daily the day after the procedure of rotational atherectomy and angioplasty (Day +1). Receives: Drug: clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
area under the curve corresponding to troponin level as a function of time
Troponin kinetics during the first 24 hours following rotational atherectomy.
Measured: up to 24 hours
Secondary outcomes (2)
area under the curve corresponding to troponin level as a function of time
Measured: up to 36 hours
Frequence of clinical events during the in-hospital period
- Major life-threatening bleeding
- Minor bleeding leading to clinically significant disability
- Death from any cause,
- Acute coronary syndrome with or without ST elevation,
- Ischemic stroke,
- In-stent thrombosis,
- Coronary dissection or perforation,
- Bail-out requiring anti GPIIb-IIIa administration.
Measured: One day before the procedure until 36 hours after.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2015 (estimated)
- Study startNov 2015
- Primary completion24 May 2018
- Study completion30 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Didier Didier, PHD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02505399
- Sponsor's protocol ID
- RC31/14/7445
- Acronym
- TIRATROP
- Status last verified
- May 2026
- First submitted
- 3 Jun 2015
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Lhermusier T, Motreff P, Bataille V, Cayla G, Farah B, Roncalli J, Elbaz M, Boudou N, Campello-Parada F, Bouisset F, Souteyrand G, Berard E, Bongard V, Carrie D. TIcagrelor in Rotational Atherectomy to Reduce TROPonin Enhancement: The TIRATROP Study, A Randomized Controlled Trial. J Clin Med. 2023 Feb 11;12(4):1445. doi: 10.3390/jcm12041445.
PubMed 36835980
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TIcagrelor in Rotational Atherectomy to Reduce TROPonin Enhancement: the TIRATROP Study, a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02505399
- Acronym / sponsor ID
- TIRATROP / RC31/14/7445
- Conditions
- Atherosclerosis
- Keywords
- Rotational Atherectomy, clopidogrel, thrombosis, ticagrelor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- 24 May 2018 (actual)
- Study completion
- 30 May 2018 (actual)
- First posted
- 22 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ticagrelor | Experimental | Drug: ticagrelorIn the intervention group, Ticagrelor will be administered orally, according to the following scheme: * 180 mg the evening preceding (and at least 6 hours before) rotational atherectomy (Day -1), * 90 mg the following morning (D Day before rotational atherectomy and angioplasty), * 90 mg the following evening (D Day after rotational atherectomy and angioplasty), * 90 mg twice daily the day after the procedure of rotational atherectomy and angioplasty (Day +1). |
| clopidogrel | Active comparator | Drug: clopidogrelIn the control group, Clopidogrel will be administered orally, according to the following scheme: * 300 mg the evening preceding (and at least 6 hours before) rotational atherectomy (Day -1), * 75 mg the following morning (D Day before rotational atherectomy and angioplasty), * 0 mg the following evening (D Day after rotational atherectomy and angioplasty), * 75 mg once daily the day after the procedure of rotational atherectomy and angioplasty (Day +1). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (32 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ticagrelorAlso: ticagrelor per osTicagrelor will be administered orally, according to the following scheme: * 180 mg the evening preceding (and at least 6 hours before) rotational atherectomy (Day -1), * 90 mg the following morning (D Day before rotational atherectomy and angioplasty), * 90 mg the following evening (D Day after rotational atherectomy and angioplasty), * 90 mg twice daily the day after the procedure of rotational atherectomy and angioplasty (Day +1). | Drug | ticagrelor |
| clopidogrelAlso: clopidrogel per osClopidogrel will be administered orally, according to the following scheme: * 300 mg the evening preceding (and at least 6 hours before) rotational atherectomy (Day -1), * 75 mg the following morning (D Day before rotational atherectomy and angioplasty), * 0 mg the following evening (D Day after rotational atherectomy and angioplasty), * 75 mg once daily the day after the procedure of rotational atherectomy and angioplasty (Day +1). | Drug | clopidogrel |
Primary outcome
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.
2 secondary outcomes
area under the curve corresponding to troponin level as a function of time
Time frame: up to 36 hours
Frequence of clinical events during the in-hospital period
Time frame: One day before the procedure until 36 hours after.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Results publication: PubMed 36835980Lhermusier T, Motreff P, Bataille V, Cayla G, Farah B, Roncalli J, Elbaz M, Boudou N, Campello-Parada F, Bouisset F, Souteyrand G, Berard E, Bongard V, Carrie D. TIcagrelor in Rotational Atherectomy to Reduce TROPonin Enhancement: The TIRATROP Study, A Randomized Controlled Trial. J Clin Med. 2023 Feb 11;12(4):1445. doi: 10.3390/jcm12041445.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Didier Didier, PHD principal investigator
University Hospital, Toulouse
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ticagrelor and clopidogrel in people with Atherosclerosis, run by University Hospital, Toulouse at 4 sites in France.
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 32 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 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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?
area under the curve corresponding to troponin level as a function of time (time frame: up to 24 hours). 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 NCT02505399, which also lists 1 linked publication.
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 Jun 2026.