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

Primary Purpose

Acute Coronary Syndrome

Status
Recruiting
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Ticagrelor 90mg twice daily and ASA 75-100 mg daily
ASA 75-160 mg daily
Sponsored by
Vastra Gotaland Region
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring Coronary Bypass Grafting, Antiplatelet treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aalborg University HospitalRecruiting
  • Aarhus University HospitalRecruiting
  • RigshospitaletRecruiting
  • Odense University HospitalRecruiting
  • Helsinki University Hospital
  • Kuopio University Hospital
  • Oulu University Hospital
  • Tampere University Hospital
  • Turku University HospitalRecruiting
  • Landspítali University HospitalRecruiting
  • St. Olavs hospital, University HospitalRecruiting
  • Oslo University HospitalRecruiting
  • University Hospital of North NorwayRecruiting
  • Haukeland University HospitalRecruiting
  • Sahlgrenska University HospitalRecruiting
  • Blekinge HospitalRecruiting
  • Linköping University HospitalRecruiting
  • Skåne University HospitalRecruiting
  • Karolinska University HospitalRecruiting
  • University Hospital of UmeåRecruiting
  • Uppsala University HospitalRecruiting
  • Örebro University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dual antiplatelet therapy

Acetylsalicylic acid

Arm Description

Ticagrelor 90 mg twice daily and ASA 75-100 mg daily for 12 months

ASA 75-160 mg daily for 12 months

Outcomes

Primary Outcome Measures

Time to major adverse cardiovascular events (MACE)
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

Time to all cause death
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
Time to all cause death, myocardial infarction or stroke
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.
Time to cardiovascular death
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
Time to first myocardial infarction
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
Time to first stroke
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
Time to new revascularization
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
Time to coronary angiography
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
Time to hospitalization for heart failure
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
Time to cardiovascular hospitalization
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
Time to sudden death or aborted cardiac arrest
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
Time to new-onset atrial fibrillation
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
Time to major bleeding defined as bleeding requiring hospitalization
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
Time to minor bleeding
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
Time to any bleeding
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
Time to dyspnea
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
Time to dyspnea causing drug interruption
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
Time to new onset renal failure
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
Time to major adverse cardiovascular events (MACE)
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.

Full Information

First Posted
June 1, 2018
Last Updated
April 6, 2021
Sponsor
Vastra Gotaland Region
Collaborators
Gothia Forum - Center for Clinical Trial, Uppsala University
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1. Study Identification

Unique Protocol Identification Number
NCT03560310
Brief Title
Ticagrelor and ASA vs. ASA Only After Isolated Coronary Artery Bypass Grafting in Patients With Acute Coronary Syndrome
Acronym
TACSI
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Recruiting
Study Start Date
June 29, 2018 (Actual)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
June 2031 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vastra Gotaland Region
Collaborators
Gothia Forum - Center for Clinical Trial, Uppsala University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
Keywords
Coronary Bypass Grafting, Antiplatelet treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Parallel treatment arms.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dual antiplatelet therapy
Arm Type
Experimental
Arm Description
Ticagrelor 90 mg twice daily and ASA 75-100 mg daily for 12 months
Arm Title
Acetylsalicylic acid
Arm Type
Active Comparator
Arm Description
ASA 75-160 mg daily for 12 months
Intervention Type
Drug
Intervention Name(s)
Ticagrelor 90mg twice daily and ASA 75-100 mg daily
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
ASA 75-160 mg daily
Intervention Description
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 Measure Information:
Title
Time to major adverse cardiovascular events (MACE)
Description
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.
Time Frame
within12 months
Secondary Outcome Measure Information:
Title
Time to all cause death
Description
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
Time Frame
within 12 months
Title
Time to all cause death, myocardial infarction or stroke
Description
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.
Time Frame
within 12 months
Title
Time to cardiovascular death
Description
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
Time Frame
within 12 months
Title
Time to first myocardial infarction
Description
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
Time Frame
within 12 months
Title
Time to first stroke
Description
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
Time Frame
within 12 months
Title
Time to new revascularization
Description
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
Time Frame
within 12 months
Title
Time to coronary angiography
Description
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
Time Frame
within 12 months
Title
Time to hospitalization for heart failure
Description
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
Time Frame
within 12 months
Title
Time to cardiovascular hospitalization
Description
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
Time Frame
within 12 months
Title
Time to sudden death or aborted cardiac arrest
Description
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
Time Frame
within 12 months
Title
Time to new-onset atrial fibrillation
Description
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
Time Frame
within 12 months
Title
Time to major bleeding defined as bleeding requiring hospitalization
Description
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
Time Frame
within 12 months
Title
Time to minor bleeding
Description
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
Time Frame
within 12 months
Title
Time to any bleeding
Description
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
Time Frame
within 12 months
Title
Time to dyspnea
Description
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
Time Frame
within 12 months
Title
Time to dyspnea causing drug interruption
Description
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
Time Frame
within 12 months
Title
Time to new onset renal failure
Description
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
Time Frame
within 12 months
Title
Time to major adverse cardiovascular events (MACE)
Description
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.
Time Frame
2, 3, 5 and 10 years after the patient has been included in the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Written informed consent Age ≥18 years 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: Previously enrolled in this study (i.e. patient now at repeat encounter) Concomitant surgical procedure other than CABG Anticoagulant treatment after the operation (e.g. warfarin, direct thrombin inhibitors (dabigatran), FXa inhibitors (rivaroxaban, apixaban, heparin, low-molecular weight heparin, fondaparinux) Discharge from the operating hospital to an ICU at another hospital Pregnancy or lactation Known intolerance or contraindication to ticagrelor or ASA Any disorder that may interfere with drug absorption Any condition other than coronary artery disease with a life expectancy <12 months Known chronic liver disease, renal disease requiring dialysis or bleeding disorder Atrioventricular block II and III in patients without pacemaker Any other indication for dual antiplatelet therapy, i.e. recent stent implantation Debilitating stroke within 90 days before inclusion Previous intracranial bleeding Treatment with immunosuppressants (e.g. cyclosporine and tacrolimus) Treatment with strong CYP3A4-inhibitors (e.g. ketoconazole, clarithromycin, nefazodone, ritonavir or atazanavir) Any condition that in the opinion of the investigator may interfere with adherence to trial protocol Participation in any other clinical trial evaluating investigational products at the time for enrollment in this study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anders Jeppsson, MD,PhD,Prof
Phone
+46 (0)736 601787
Email
anders.jeppsson@vgregion.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anders Jeppssson, MD,PhD,Prof.
Organizational Affiliation
Dep. of Cardiothoracic Surgery , Sahlgrenska University Hospital, 413 45 Gothenburg, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aalborg University Hospital
City
Aalborg
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gennady Atroshchenko
Facility Name
Aarhus University Hospital
City
Aarhus
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ivy Modrau
Facility Name
Rigshospitalet
City
Copenhagen
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Møller
Facility Name
Odense University Hospital
City
Odense
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lars Peter Riber
Facility Name
Helsinki University Hospital
City
Helsinki
Country
Finland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annu Nummi
Facility Name
Kuopio University Hospital
City
Kuopio
Country
Finland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annastiina Husso
Facility Name
Oulu University Hospital
City
Oulu
Country
Finland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Toumas Mäkelä
Facility Name
Tampere University Hospital
City
Tampere
Country
Finland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ari Mennander
Facility Name
Turku University Hospital
City
Turku
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jarmo Gunn
Facility Name
Landspítali University Hospital
City
Reykjavík
Country
Iceland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tomas Gudbjartsson
Facility Name
St. Olavs hospital, University Hospital
City
Bergen
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Wahba
Facility Name
Oslo University Hospital
City
Oslo
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Theis Tønnessen
Facility Name
University Hospital of North Norway
City
Tromsø
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Øyvind Jakobsen
Facility Name
Haukeland University Hospital
City
Trondheim
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rune Haaverstad
Facility Name
Sahlgrenska University Hospital
City
Gothenburg
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carl Johan Malm
Facility Name
Blekinge Hospital
City
Karlskrona
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikael Barbu
Facility Name
Linköping University Hospital
City
Linköping
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Farkas Vanky
Facility Name
Skåne University Hospital
City
Lund
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shahaab Nozohoor
Facility Name
Karolinska University Hospital
City
Stockholm
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ulrik Sartipy
Facility Name
University Hospital of Umeå
City
Umeå
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anders Holmgren
Facility Name
Uppsala University Hospital
City
Uppsala
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lena Jideus
Facility Name
Örebro University Hospital
City
Örebro
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mats Dreifaldt

12. IPD Sharing Statement

Plan to Share IPD
No

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

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