SAPT Versus DAPT in Incomplete Revascularization After CABG

Last updated: July 19, 2022
Sponsor: Campus Bio-Medico University
Overall Status: Active - Recruiting

Phase

3

Condition

Myocardial Ischemia

Hypercholesterolemia

Coronary Artery Disease

Treatment

N/A

Clinical Study ID

NCT03789916
72.18
  • Ages > 18
  • All Genders

Study 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 DAPT will be continued for 12 months, and ticagrelor will be withdrawn thereafter.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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • patients undergoing CABG, ± cardiopulmonary bypass, ± any associated cardiacprocedures (valve replacement,...)
  • incomplete myocardial revascularization, defined by anatomic or functional criteria
  • obtained informed consent

Exclusion

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  • surgical treatment requiring DAPT withdrawn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

Study Design

Total Participants: 800
Study Start date:
January 02, 2019
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Università Campus Bio-Medico di Roma

    Rome, 00128
    Italy

    Active - Recruiting

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