TIcagrelor in Rotational Atherectomy to Reduce TROPonin Enhancement

Status Completed

Clinical 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. 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.

Clinical Trial 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

Related Conditions & MeSH terms

Atherosclerosis

Clinical Trial Details

NCT number	NCT02505399
Study type	Interventional
Source	University Hospital, Toulouse
Contact
Status	Completed
Phase	Phase 4
Start date	November 2015
Completion date	May 30, 2018

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05052918` - The Effect of Exercise and Metformin on Carotid Intima-media Thickness in Patients With Prediabetes	N/A
Recruiting	`NCT04511234` - Sirolimus Coated Balloon Versus Standard Balloon for SFA and Popliteal Artery Disease	N/A
Completed	`NCT05906797` - Impact of Non-surgical Periodontal Therapy in the Improvement of Early Endothelial Dysfunction in Subjects With Periodontitis.	N/A
Completed	`NCT03273972` - INvestigating the Lowest Threshold of Vascular bENefits From LDL Lowering With a PCSK9 InhibiTor in healthY Volunteers	N/A
Suspended	`NCT02932176` - Machine Learning for Handheld Vascular Studies
Recruiting	`NCT05158257` - Clinical Of Plain Balloon Dilatation Combined Stent Versus Endovascular Debulking Combined Drug-coated Balloon to Treat Arteriosclerosis Occlusive Disease of Lower Extremity	N/A
Completed	`NCT01212900` - Randomized Trial of Imaging Versus Risk Factor-Based Therapy for Plaque Regression	Phase 4
Completed	`NCT03697382` - Effect of Daily Steps on Fat Metabolism	N/A
Recruiting	`NCT06230406` - T-Mem GEne in Atherosclerosis
Completed	`NCT03654313` - Single and Multiple Ascending Doses of MEDI6570 in Subjects With Type 2 Diabetes Mellitus	Phase 1
Completed	`NCT00382564` - Magnetic Resonance Angiography to Diagnose Atherosclerotic Disease	N/A
Recruiting	`NCT02894931` - Effects of Dietary Interventions on Serum and Macrophage Atherogenicity	N/A
Completed	`NCT02998918` - Effects of Short-term Curcumin and Multi-polyphenol Supplementation on the Anti-inflammatory Properties of HDL	N/A
Not yet recruiting	`NCT02578355` - National Plaque Registry and Database	N/A
Recruiting	`NCT02265250` - Pilot Study-Magnetic Resonance Imaging for Global Atherosclerosis Risk Assessment
Completed	`NCT03393377` - Preventive Arterial Wall Phenotype and Low-dose Fluvastatin/Valsartan Combination	N/A
Completed	`NCT02224339` - New Technologies to Determine Carotid Plaque Vulnerability
Completed	`NCT02268513` - Mediators of Atherosclerosis in South Asians Living in America (MASALA) Social Network Study
Completed	`NCT02116829` - Is There Room for Butter in a Healthy Diet?	N/A
Not yet recruiting	`NCT01923012` - Phase II Randomized Placebo-controlled Study With Vitamin K2 in Asymptomatic Calcified Carotid Stenosis	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

TIcagrelor in Rotational Atherectomy to Reduce TROPonin Enhancement — TIRATROP

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms