Safety Profile Evaluation of TICagrelor Alone Compared to a Combination of Lysine Acetylsalicylate-Clopidogrel in the Context of Transcatheter Aortic Valve Implantation (TAVI)

NCT ID: NCT02817789

Last Updated: 2022-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-09
• Study Completion Date: 2018-05-30

Brief Summary

Transcatheter Aortic Valve Implantation (TAVI) is now the method of choice to treat aortic stenosis in old and frail patients. Antiplatelet therapy must be associated for the procedure and during few weeks after implantation in the aim to minimize cerebral embolization. But for now, the best antiplatelet regimen has to be determined. In this context, investigators want to evaluate the safety of use of ticagrelor alone versus standardized therapy which involves lysine acetylsalicylate and clopidogrel. In this study, we will randomly compare 154 patients in each group in terms of early safety (30 days) after the procedure.

Detailed Description

In spite of the use of the combination of lysine acetylsalicylate and clopidogrel during and after the procedure of TAVI, rates of stroke remains high, between 4 and 10% regarding the studies and registries. None of the therapeutics have regulatory authorisation for this indication. On the other hand, the rates of bleeding events are also high in this old and frail population. That is why, considering its pharmacological specificity, investigators hypothesize that ticagrelor, used alone, could be non-inferior on safety criteria than the combination of lysine acetylsalicylate and clopidogrel. Our study want to evaluate the safety profile of Ticagrelor alone (180 mg loading dose before intervention and 90 mg twice daily during 30 days after the procedure) compared to the standardized treatment combining lysine acetylsalicylate (75 mg before and 75 mg daily after the procedure) and clopidogrel (300mg loading dose before and 75 mg daily after the procedure). Patients will be followed during one month. Then they will be all placed under the usual antiplatelet treatment (clopidogrel and lysine acetylsalicylate for two additional months and then lysine acetylsalicylate alone lifelong).

Conditions

Aortic Valve Stenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Standard group

154 patients

Group Type: ACTIVE_COMPARATOR

Combination lysine acetylsalicylate - clopidogrel

Intervention Type: DRUG

75 mg before and 75 mg daily after the procedure of lysine acetylsalicylate and 300mg loading dose before and 75 mg of clopidogrel daily after the procedure

Ticagrelor group

154 patients

Group Type: EXPERIMENTAL

Ticagrelor alone

Intervention Type: DRUG

180 mg loading dose before intervention and 90 mg twice daily during 30 days after the procedure

Interventions

Ticagrelor alone

180 mg loading dose before intervention and 90 mg twice daily during 30 days after the procedure

Intervention Type: DRUG

Combination lysine acetylsalicylate - clopidogrel

75 mg before and 75 mg daily after the procedure of lysine acetylsalicylate and 300mg loading dose before and 75 mg of clopidogrel daily after the procedure

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Provision of informed consent prior to any study specific procedures
• Female or male aged > 18 years
• Patient eligible for TAVI as recommended by French health care system authority (HAS)

Exclusion Criteria

• Allergy, hypersensitivity, or contraindication to lysine acetylsalicylate, clopidogrel, ticagrelor, any anticoagulation or magnetic resonance imaging (MRI) or CT-scanner contrast agents
• Use of Cytochrome P3a (CYP3a) inhibitor
• Need for chronic anticoagulation
• Previous percutaneous coronary intervention or acute coronary syndrome requiring dual antiplatelet therapy
• Previous cardiac surgery for valve replacement
• Prior stroke, transient ischemic attack (TIA) or known carotid stenosis > 70%
• Active pathological bleeding or gastric ulcer < 3month
• Known thrombocytopenia, anemia or any coagulopathy
• Severe kidney or hepatic impairment
• Hemodynamic instability
• Refusal of Transfusion
• Significant mental impairment
• Inability to give informed consent or comply with study related procedures or high likelihood of being unavailable for follow-up
• Pregnant or breastfeeding women
• Women of childbearing potential without effective contraception (oestroprogestative, intrauterine devices)
• Participant in another investigational drug or device study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lionel LEROUX, Dr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

CHRU de Lille

Lille, , France

APHM

Marseille, , France

CHRU de Nîmes

Nîmes, , France

APHP

Paris, , France

CHU de Bordeaux

Pessac, , France

Countries

France

Other Identifiers

CHUBX 2014/24

Identifier Type: -

Identifier Source: org_study_id