Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

SAPT Versus DAPT in Incomplete Revascularization After CABG (SDAT-IRC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03789916
Recruitment Status : Recruiting
First Posted : December 31, 2018
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
Antonio Nenna, MD, Campus Bio-Medico University

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 DAPT will be continued for 12 months, and ticagrelor will be withdrawn thereafter.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
Coronary Artery Disease Drug: Ticagrelor Drug: acetylsalicylic acid Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 2, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2026

Resource links provided by the National Library of Medicine

Drug Information available for: Ticagrelor

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 Name: Brilique

Drug: acetylsalicylic acid
100 mg die

Active Comparator: SAPT
"Single antiplatelet therapy": acetylsalicylic acid 100 mg/die
Drug: acetylsalicylic acid
100 mg die




Primary Outcome Measures :
  1. Cardiac-related mortality [ Time Frame: 5 years ]

Secondary Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03789916


Contacts
Layout table for location contacts
Contact: Antonio Nenna, MD +393337014743 a.nenna@unicampus.it
Contact: Massimo Chello, MD m.chello@unicampus.it

Locations
Layout table for location information
Italy
Università Campus Bio-Medico di Roma Recruiting
Rome, Italy, 00128
Contact: Antonio Nenna, MD    +393337014743    a.nenna@unicampus.it   
Contact: Massimo Chello, MD       m.chello@unicampus.it   
Principal Investigator: Antonio Nenna, MD         
Principal Investigator: Massimo Chello, MD         
Sponsors and Collaborators
Campus Bio-Medico University
Investigators
Layout table for investigator information
Study Chair: Massimo Chello, MD Università Campus Bio-Medico di Roma, Rome, Italy

Publications of Results:
Layout table for additonal information
Responsible Party: Antonio Nenna, MD, Cardiovascular Surgery, Campus Bio-Medico University
ClinicalTrials.gov Identifier: NCT03789916     History of Changes
Other Study ID Numbers: 72.18
First Posted: December 31, 2018    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)

Layout table for additional information
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, Campus Bio-Medico University:
coronary artery bypass grafting
incomplete revascularization
coronary artery disease
dual antiplatelet therapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Aspirin
Ticagrelor
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics