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NCT Number: NCT03789916

SAPT Versus DAPT in Incomplete Revascularization After CABG

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 DAPT will be continued for 12 months, and ticagrelor will be withdrawn thereafter.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

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Università Campus Bio-Medico di Roma

Rome, 00128, Italy

Location status: Recruiting

Location contact

Antonio Nenna, MD

CONTACT

[email protected]

+393337014743

Antonio Nenna, MD

PRINCIPAL_INVESTIGATOR

Massimo Chello, MD

CONTACT

[email protected]

Massimo Chello, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ticagrelor

Drug

90 mg bis in die

Other names: Brilique

acetylsalicylic acid

Drug

100 mg die

Primary outcomes

  1. Cardiac-related mortality

    Time frame: 5 years

Secondary outcomes

  1. Mortality

    Time frame: 5 years

    Overall mortality and non-cardiac-related mortality

  2. Major adverse cardiac and cerebrovascular events (MACCEs)

    Time frame: 5 years

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

  3. Major adverse hemorrhagic events (MAHEs)

    Time frame: 5 years

    stroke, gastrointestinal bleeding, life-threatening bleeding

Study contacts

Contact information is provided by the study sponsor or research team.

Antonio Nenna, MD

CONTACT

[email protected]

+393337014743

Massimo Chello, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Campus Bio-Medico University

Other

Registry information

Official study title

Single Versus Dual Antiplatelet Therapy in Patients With Incomplete Revascularization After Coronary Artery Bypass Graft Surgery

Acronym: SDAT-IRC

Important dates

Study start
2019
Primary completion
2021
Study completion
2026
First posted
Dec 31, 2018
Registry last updated
Jul 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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