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Ticagrelor and ASA vs. ASA Only After Isolated Coronary Artery Bypass Grafting in Patients With Acute Coronary Syndrome (TACSI)

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ClinicalTrials.gov Identifier: NCT03560310
Recruitment Status : Recruiting
First Posted : June 18, 2018
Last Update Posted : April 8, 2019
Sponsor:
Collaborators:
Gothia Forum - Center for Clinical Trial
Uppsala University
Information provided by (Responsible Party):
Vastra Gotaland Region

Brief Summary:
The study is a Randomised Registry-based Clinical Trial (RRCT) to assess whether dual antiplatelet therapy with ticagrelor and ASA compared to ASA alone improves outcome after isolated CABG in patients with acute coronary syndrome.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Drug: Ticagrelor 90mg twice daily and ASA 75-100 mg daily Drug: ASA 75-160 mg daily Phase 4

Detailed Description:

The trial is a 1:1 randomized, interventional, multi-national, multi-center, safety/efficacy, parallel assignment, open-label treatment study and will use the RRCT methodology. A RRCT study utilizes existing health care registry platforms to conduct a pragmatic prospective randomized trial.

After the CABG, eligible patients that have consented to the study, will be randomized to either treatment arms. In the intervention arm, patients will be treated with ticagrelor 90 mg twice daily and ASA 75-100 mg daily for 12 months and patients in the control arm will get ASA only (75-160 mg daily according to local guidelines) during the same time period.

The patients will be followed by telephone interviews at 30 days and 365 days after inclusion. After the treatment period patients will be followed during an observation period by collection of outcome data from registries or medical records, 24, 36, 60 and 120 months after inclusion of the patient. No other data but the registry data or data from medical records will be collected.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel treatment arms.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dual Antiplatelet Therapy With Ticagrelor and Acetylsalicylic Acid (ASA) vs. ASA Only After Isolated Coronary Artery Bypass Grafting in Patient With Acute Coronary Syndrome
Actual Study Start Date : June 29, 2018
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2031

Resource links provided by the National Library of Medicine

Drug Information available for: Ticagrelor

Arm Intervention/treatment
Experimental: Dual antiplatelet therapy
Ticagrelor 90 mg twice daily and ASA 75-100 mg daily for 12 months
Drug: Ticagrelor 90mg twice daily and ASA 75-100 mg daily
Assess whether ticagrelor 90 mg twice daily and ASA 75-100 mg daily versus ASA 75-160 mg daily improves outcome after isolated coronary artery bypass grafting in patients with acute coronary syndrome

Active Comparator: Acetylsalicylic acid
ASA 75-160 mg daily for 12 months
Drug: ASA 75-160 mg daily
Assess whether ticagrelor 90 mg twice daily and ASA 75-100 mg daily versus ASA 75-160 mg daily improves outcome after isolated coronary artery bypass grafting in patients with acute coronary syndrome




Primary Outcome Measures :
  1. Time to major adverse cardiovascular events (MACE) [ Time Frame: within12 months ]
    To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone improves 12 months outcome defined as time to major adverse cardiovascular events (MACE) after isolated CABG in ACS patients. MACE includes all-cause mortality, myocardial infarction, stroke and new revascularization.


Secondary Outcome Measures :
  1. Time to all cause death [ Time Frame: within 12 months ]
    To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone influences all cause death within 12 months after randomization

  2. Time to all cause death, myocardial infarction or stroke [ Time Frame: within 12 months ]
    To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone improves 12 months outcome defined as time to a composite endpoint of all cause death, myocardial infarction or stroke after isolated CABG in ACS patients.

  3. Time to cardiovascular death [ Time Frame: within 12 months ]
    To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone influences cardiovascular death within 12 months after randomization

  4. Time to first myocardial infarction [ Time Frame: within 12 months ]
    To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone influences myocardial infarction within 12 months after randomization

  5. Time to first stroke [ Time Frame: within 12 months ]
    To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone influences the incidence of stroke within 12 months after randomization

  6. Time to new revascularization [ Time Frame: within 12 months ]
    To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone influences the incidence of new revascularization within 12 months after randomization

  7. Time to coronary angiography [ Time Frame: within 12 months ]
    To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone influences the incidence of coronary angiography within 12 months after randomization

  8. Time to hospitalization for heart failure [ Time Frame: within 12 months ]
    To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone influences the incidence of heart failure within 12 months after randomization

  9. Time to cardiovascular hospitalization [ Time Frame: within 12 months ]
    To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone influences the incidence of cardiovascular hospitalization within 12 months after randomization

  10. Time to sudden death or aborted cardiac arrest [ Time Frame: within 12 months ]
    To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone influences the incidence of sudden death or aborted cardiac arrest within 12 months after randomization

  11. Time to new-onset atrial fibrillation [ Time Frame: within 12 months ]
    To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone influences the incidence of new-onset atrial fibrillation within 12 months after randomization

  12. Time to major bleeding defined as bleeding requiring hospitalization [ Time Frame: within 12 months ]
    To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone influences the incidence of major bleeding within 12 months after randomization

  13. Time to minor bleeding [ Time Frame: within 12 months ]
    To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone influences the incidence of minor bleeding within 12 months after randomization

  14. Time to any bleeding [ Time Frame: within 12 months ]
    To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone influences the incidence of any bleeding within 12 months after randomization

  15. Time to dyspnea [ Time Frame: within 12 months ]
    To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone influences the incidence of dyspnea within 12 months after randomization

  16. Time to dyspnea causing drug interruption [ Time Frame: within 12 months ]
    To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone influences the incidence of dyspnea causing drug interruption within 12 months after randomization

  17. Time to new onset renal failure [ Time Frame: within 12 months ]
    To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone influences the incidence of new onset renal failure within 12 months after randomization

  18. Time to major adverse cardiovascular events (MACE) [ Time Frame: 2, 3, 5 and 10 years after the patient has been included in the study ]
    To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone improves long-term outcome defined as time to major adverse cardiovascular events (MACE) after isolated CABG in ACS patients. MACE includes all-cause mortality, myocardial infarction, stroke and new revascularization.



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

Inclusion Criteria:

  1. Written informed consent
  2. Age ≥18 years
  3. Has undergone first time isolated CABG due to an episode of acute coronary syndrome (STEMI, NSTEMI, unstable angina) within 6 weeks before surgery

Exclusion Criteria:

  1. Previously enrolled in this study (i.e. patient now at repeat encounter)
  2. Concomitant surgical procedure other than CABG
  3. Anticoagulant treatment after the operation (e.g. warfarin, direct thrombin inhibitors (dabigatran), FXa inhibitors (rivaroxaban, apixaban, heparin, low-molecular weight heparin, fondaparinux)
  4. Discharge from the operating hospital to an ICU at another hospital
  5. Pregnancy or lactation
  6. Known intolerance or contraindication to ticagrelor or ASA
  7. Any disorder that may interfere with drug absorption
  8. Any condition other than coronary artery disease with a life expectancy <12 months
  9. Known chronic liver disease, renal disease requiring dialysis or bleeding disorder
  10. Atrioventricular block II and III in patients without pacemaker
  11. Any other indication for dual antiplatelet therapy, i.e. recent stent implantation
  12. Debilitating stroke within 90 days before inclusion
  13. Previous intracranial bleeding
  14. Treatment with immunosuppressants (e.g. cyclosporine and tacrolimus)
  15. Treatment with strong CYP3A4-inhibitors (e.g. ketoconazole, clarithromycin, nefazodone, ritonavir or atazanavir)
  16. Any condition that in the opinion of the investigator may interfere with adherence to trial protocol
  17. Participation in any other clinical trial evaluating investigational products at the time for enrollment in this study

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): NCT03560310


Contacts
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Contact: Anders Jeppsson, MD,PhD,Prof +46 (0)736 601787 anders.jeppsson@vgregion.se

Locations
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Sweden
Sahlgrenska University Hospital Recruiting
Gothenburg, Sweden
Contact: Carl Johan Malm         
Blekinge Hospital Not yet recruiting
Karlskrona, Sweden
Contact: Mikael Barbu         
Linköping University Hospital Recruiting
Linköping, Sweden
Contact: Farkas Vanky         
Skåne University Hospital Recruiting
Lund, Sweden
Contact: Shahaab Nozohoor         
Karolinska University Hospital Recruiting
Stockholm, Sweden
Contact: Ulrik Sartipy         
University Hospital of Umeå Not yet recruiting
Umeå, Sweden
Contact: Anders Holmgren         
Uppsala University Hospital Recruiting
Uppsala, Sweden
Contact: Lena Jideus         
Örebro University Hospital Not yet recruiting
Örebro, Sweden
Contact: Mats Dreifaldt         
Sponsors and Collaborators
Vastra Gotaland Region
Gothia Forum - Center for Clinical Trial
Uppsala University
Investigators
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Principal Investigator: Anders Jeppssson, MD,PhD,Prof. Dep. of Cardiothoracic Surgery , Sahlgrenska University Hospital, 413 45 Gothenburg, Sweden

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Responsible Party: Vastra Gotaland Region
ClinicalTrials.gov Identifier: NCT03560310     History of Changes
Other Study ID Numbers: EudraCT 2017-001499-43
First Posted: June 18, 2018    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Vastra Gotaland Region:
Coronary Bypass Grafting
Antiplatelet treatment

Additional relevant MeSH terms:
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Syndrome
Acute Coronary Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Ticagrelor
Aspirin
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