Aspirin versus Aspirin plus Clopidogrel in Patients Undergoing Transcatheter Aortic ValveReplacement: a Randomized Multicenter Study

Phase 1

• Conditions: valvular aortic stenosis submitted to TAVI; MedDRA version: 20.0Level: PTClassification code 10002918Term: Aortic valve stenosisSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2018-000608-40-IT
• Lead Sponsor: AOU DI BOLOGNA POLICLINICO S.ORSOLA-MALPIGHI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-10
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 762

Inclusion Criteria

1) Patients undergoing an effective and uncomplicated procedure. Effective TAVI intervention means the correct positioning of a single aortic prosthesis in the appropriate anatomic site, with a residual gradient <20 mmHg and in the absence of severe aortic valvular insufficiency. Uncomplicated TAVI intervention means an effective implantation of prostheses in the absence of strokes, major bleeding types 3b, 3c or 5 according to the BARC definition, vascular complications according to the VARC definition (Table 1), coronary obstruction, or acute valvular dysfunction requires a new implant of prosthesis or surgical conversion.
2) Age> 18 years
3) Obtaining informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 462
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 300

Exclusion Criteria

1) Need of anticoagulant therapy;
2) Medicated stent implant within 12 months prior to randomization;
3) Note or suspected hypersensitivity to ASA or clopidogrel;
4) Women of childbearing age;
5) Participation in another study protocol;
6) Ejection fraction <20%;
7) Acute coronary syndrome within the year preceding randomization;
8) Major bleeding event within 5 years from randomization;
9) Hemoglobin levels lower than 8 mg / dl;
10) History of asthma induced by administration of acetylsalicylates;
11) Evidence of gastric ulcer, duodenal or esophageal ulcer with active bleeding or clinically significant gastrointestinal bleeding within 8 weeks prior to randomization;
12) Any constitutional or acquired haemorrhagic disease;
13) Impaired renal function defined by eGFR values ¿¿<30 mL / min / 1.73 m2;
14) Hepatic pathology defined by serum ALT (SGPT), AST (SGOT), or alkaline phosphatase levels higher than 3 times the upper limit of normality;
15) Concomitant treatment with methotrexate at doses of 15 mg / week or more;
16) Pre-existing mastocytosis, in patients in whom the use of acetylsalicylic acid can induce serious hypersensitivity reactions;
17) Documented or suspected active malignant neoplasia or previous history, within 2 years prior to randomization;
18) Patients who must or want to continue taking illicit drugs or drugs that can interfere with the proper conduct of the study;
19) Chronic abuse of alcohol or drugs or any condition that in the judgment of the investigator doctor makes an unreliable subject in correctly completing the procedures of the study;
20) Any other clinical condition that would endanger the safety of patients in participating in the study or that could prevent the subjects from adhering to the protocol.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified