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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ticagrelor | Experimental | In the intervention group, Ticagrelor will be administered orally, according to the following scheme:
|
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| clopidogrel | Active Comparator | In the control group, Clopidogrel will be administered orally, according to the following scheme:
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ticagrelor | Drug | Ticagrelor will be administered orally, according to the following scheme:
|
| Measure | Description | Time Frame |
|---|---|---|
| area under the curve corresponding to troponin level as a function of time | Troponin kinetics during the first 24 hours following rotational atherectomy. | up to 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| area under the curve corresponding to troponin level as a function of time | up to 36 hours | |
| Frequence of clinical events during the in-hospital period |
|
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Inclusion criteria :
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):
Other conditions at increased risk of bleeding:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Didier Didier, PHD | University Hospital, Toulouse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Pasteur | Toulouse | Haute-Garonne | 31000 | France | ||
| Fédération de Cardiologie CHU TOULOUSE |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36835980 | Result | 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. |
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| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077486 | Ticagrelor |
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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|
|
| clopidogrel | Drug | Clopidogrel will be administered orally, according to the following scheme:
|
|
|
| One day before the procedure until 36 hours after. |
| Toulouse |
| Haute-Garonne |
| 31059 |
| France |
| Hospices civils de Lyon | Lyon | 69000 | France |
| University Hospital | Nîmes | 30000 | France |
| D016769 |
| Embolism and Thrombosis |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |