Completed

Ticagrelor and Aspirin vs. Standard Dual Anti-Platelet Therapy After Stent Implantation

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Study Aim

This study aims to evaluate the effectiveness of Ticagrelor and Aspirin compared to standard dual anti-platelet therapy after stent implantation, by observing the number of participants with a composite of all-cause mortality or non-fatal new Q-wave Myocardial Infarction (MI) up to 2 years post randomisation.

What is being tested

Ticagrelor

+ Acetylsalicylic Acid

+ Ticagrelor

Drug
Who is being recruted

Arterial Occlusive Diseases+5

+ Arteriosclerosis

+ Cardiovascular Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: July 2013
See protocol details

Summary

Principal SponsorECRI bv
Last updated: March 15, 2022
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2013

Actual date on which the first participant was enrolled.

The study objective is to determine in all-comers patients undergoing percutaneous coronary intervention (PCI) under standardised treatment (including the BioMatrix family of drug-eluting stents and bivalirudin), whether treatment with 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy is superior with respect to the composite of all-cause mortality or non-fatal new Q-wave myocardial infarction (MI) compared to treatment with 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy. The study design is an investigator-initiated, prospective randomised, multi-centre, multi-national, open-label trial to be conducted in approximately 60-80 interventional cardiology centres in Europe, North America, South America and Asia-Pacific. Patients will be randomised at a 1:1 ratio to study or reference treatment strategy. Randomisation will occur at the time of the index procedure prior to PCI. Subjects will be stratified according to centre and according to the clinical presentation (Stable Coronary Artery Disease (CAD) vs. Acute Coronary Syndrome (ACS)). All patients will be followed for a period of 2 years.

Principal SponsorECRI bv
Last updated: March 15, 2022
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

15991 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Arterial Occlusive DiseasesArteriosclerosisCardiovascular DiseasesCoronary DiseaseHeart DiseasesVascular DiseasesMyocardial IschemiaCoronary Artery Disease

Criteria

Inclusion Criteria: -"All comer" patients Age ≥18 years; Presence of one or more coronary artery stenoses of 50% or more in a native coronary artery or in a saphenous venous or arterial bypass conduit suitable for coronary stent implantation. The vessel should have a reference vessel diameter of at least 2.25 mm (no limitation on the number of treated lesions, vessels, or lesion length); Able to provide informed consent and willing to participate in 2 year follow- up period. Exclusion Criteria: Known intolerance to aspirin, P2Y12 inhibitors, bivalirudin, stainless steel or biolimus; Known intake of a strong CYP3A4 inhibitor (e.g., ketoconazole, clarithromycin, nefazodone, ritonavir, and atazanavir), as co-administration may lead to a substantial increase in exposure to ticagrelor; Known moderate to severe hepatic impairment (alanine-aminotransferase ≥ 3 x ULN); Planned surgery, including coronary artery bypass graft (CABG) as a staged procedure (hybrid) within 12 months of the index procedure, unless dual antiplatelet therapy is maintained throughout the peri-surgical period; Need for chronic oral anti-coagulation therapy; Active major bleeding or major surgery within the last 30 days; Known history of intracranial haemorrhagic stroke or intra-cranial aneurysm; Known stroke (any type) within the last 30 days; Known pregnancy at time of randomisation; Female who is breastfeeding at time of randomisation; Currently participating in another trial and not yet at its primary endpoint.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
All patients in the treatment group will receive acetylsalicylic acid (ASA) and ticagrelor for 1 month followed by 23 months of ticagrelor monotherapy. Dosage and frequency: Ticagrelor: 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd)

Group II

Active Comparator
Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for 12 months followed by 12 months of ASA monotherapy. Stable Coronary Artery Disease (CAD) patients: ASA and clopidogrel for 12 months followed by 12 months of ASA monotherapy. Dosage and frequency: Brilique(Ticagrelor): 90 mg b.i.d. ASA: of 75mg qd (- ≤ 100 mg qd) Clopidogrel: 75 mg qd

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 130 locations

Research centre Brisbane, 6101

Brisbane, AustraliaOpen Research centre Brisbane, 6101 in Google Maps

Research centre Melbourne, 6104

Melbourne, Australia

Research centre Melbourne, 6105

Melbourne, Australia

Research centre Graz, 4305

Graz, Austria
Completed130 Study Centers