Clincosm LogoSign in Get a demo

SDAT-IRC: SAPT Versus DAPT in Incomplete Revascularization After CABG

Sponsor
Campus Bio-Medico University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03789916
Collaborator
(none)
800
Enrollment
1
Location
2
Arms
95.9
Anticipated Duration (Months)
8.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study aims to compare the efficacy of dual antiplatelet therapy (DAPT) over single antiplatelet therapy (SAPT) in patients with incomplete revascularization after coronary artery bypass graft surgery (CABG).

Before hospital discharge, patients will be 1:1 randomized to SAPT (acetylsalicylic acid 100 mg/die) or DAPT (acetylsalicylic acid 100 mg/die + ticagrelor 90 mg bis in die). DAPT will be continued for 12 months, and ticagrelor will be withdrawn thereafter. Primary endpoint is the evaluation of cardiac-related mortality at 5 years from hospital discharge.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
800 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Single Versus Dual Antiplatelet Therapy in Patients With Incomplete Revascularization After Coronary Artery Bypass Graft Surgery
Actual Study Start Date :
Jan 2, 2019
Actual Primary Completion Date :
Aug 1, 2021
Anticipated Study Completion Date :
Dec 31, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: DAPT

"Dual antiplatelet therapy": acetylsalicylic acid 100 mg/die + ticagrelor 90 mg bis in die

Drug: Ticagrelor
90 mg bis in die
Other Names:
  • Brilique

    • Drug: acetylsalicylic acid
    100 mg die
    Active Comparator: SAPT

    "Single antiplatelet therapy": acetylsalicylic acid 100 mg/die

    Drug: acetylsalicylic acid
    100 mg die

    Outcome Measures

    Primary Outcome Measures

    1. Cardiac-related mortality [5 years]

    Secondary Outcome Measures

    1. Mortality [5 years]

      Overall mortality and non-cardiac-related mortality

    2. Major adverse cardiac and cerebrovascular events (MACCEs) [5 years]

      cardiac-related mortality, myocardial infarction, repeated vessel revascularization, hospitalization for heart failure, major arrhythmias, stroke

    3. Major adverse hemorrhagic events (MAHEs) [5 years]

      stroke, gastrointestinal bleeding, life-threatening bleeding

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • patients undergoing CABG, ± cardiopulmonary bypass, ± any associated cardiac procedures (valve replacement,...)

    • incomplete myocardial revascularization, defined by anatomic or functional criteria

    • obtained informed consent

    Exclusion Criteria:

    • acute coronary syndrome < 12 months from surgery

    • dual antiplatelet therapy at hospital admission

    • planned procedure to complete myocardial revascularization (e.g. hybrid approach)

    • intolerance / unable to take acetylsalicylic acid or ticagrelor

    • preoperative atrial fibrillation

    • impaired compliance

    • planned pregnancy

    • history of gastrointestinal bleeding

    • chronic kidney disease (eGFR < 30 mL/min/1.73 m2)

    • chronic liver disease

    • severe heart failure at hospital admission

    • active malignancy

    • alcohol abuse

    • any clinical condition not compatible with the treatment

    Exit Criteria:

    • postoperative atrial fibrillation requiring anticoagulation

    • postoperative hemorrhagic events (stroke, GI bleeding)

    • occurrence of contraindications to acetylsalicylic acid or ticagrelor

    • surgical treatment requiring DAPT withdrawn

    • patient decision

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Università Campus Bio-Medico di Roma Rome Italy 00128

    Sponsors and Collaborators

    • Campus Bio-Medico University

    Investigators

    • Study Chair: Massimo Chello, MD, Università Campus Bio-Medico di Roma, Rome, Italy

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Antonio Nenna, MD, Cardiovascular Surgery, Campus Bio-Medico University
    ClinicalTrials.gov Identifier:
    NCT03789916
    Other Study ID Numbers:
    • 72.18
    First Posted:
    Dec 31, 2018
    Last Update Posted:
    Jul 21, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Antonio Nenna, MD, Cardiovascular Surgery, Campus Bio-Medico University
    coronary artery bypass grafting
    incomplete revascularization
    coronary artery disease
    dual antiplatelet therapy
    Additional relevant MeSH terms:
    Coronary Artery Disease
    Myocardial Ischemia
    Coronary Disease
    Aspirin
    Ticagrelor

    Study Results

    No Results Posted as of Jul 21, 2022