TIcagrelor in Rotational Atherectomy to Reduce TROPonin Enhancement
- Registration Number
- NCT02505399
- Lead Sponsor
- University Hospital, Toulouse
- Brief 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. 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 180
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ticagrelor ticagrelor 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). clopidogrel clopidogrel 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).
- Primary Outcome Measures
Name Time Method area under the curve corresponding to troponin level as a function of time up to 24 hours Troponin kinetics during the first 24 hours following rotational atherectomy.
- Secondary Outcome Measures
Name Time Method 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 One day before the procedure until 36 hours after. * 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.
Trial Locations
- Locations (4)
Clinique Pasteur
🇫🇷Toulouse, Haute-Garonne, France
University Hospital
🇫🇷Nîmes, France
Hospices civils de Lyon
🇫🇷Lyon, France
Fédération de Cardiologie CHU TOULOUSE
🇫🇷Toulouse, Haute-Garonne, France