Efficacy and Safety of Low Dose Ticagrelor in Patients With Unstable Angina Pectoris After Coronary Stent Implantation

NCT03620760 | Unknown Phase 4

• 1 other identifier: 2018-2-1064
• Study Type: interventional
• Target: 2,036
• Locations: 1 country
• Sites: 1

Brief Summary

The study is to evaluate efficacy and safety of low dose of ticagrelor therapy for Chinese unstable angina patients treated with non-urgent coronary stent implantation, to examine whether lower dose ticagrelor (45 mg twice-daily) is not inferior to standard dose (90 mg twice-daily) for the prevention of major adverse cardiovascular and cerebrovascular events, as well as will reduce the incidence of bleeding during long-term treatment.

Conditions

Unstable Angina Pectoris; Coronary Stent Implantation

Keywords

Unstable Angina; Stent; Ticagrelor; Platelet aggregation; Percutaneous Coronary Intervention; Coronary Artery Disease; Major Adverse Cardiovascular and Cerebrovascular Events; Bleeding Events

Outcome Measures

Primary Outcomes (1)

• Incidence of major adverse cardiovascular and cerebrovascular events (MACCEs) and major bleeding event

  Participants with death from vascular causes, non-fatal myocardial infarction, stent thrombosis, coronary revascularization and stroke. Intention to treat (ITT) analysis of whole population. Events were adjudicated by an endpoint committee. Participants with PLATO major bleeding event including fatal bleeding, intracranial bleeding, intrapericardial bleeding with cardiac tamponade, hypovolemic shock or severe hypotension due to bleeding and requiring pressures or surgery, a decline in the hemoglobin level of 5.0 g per deciliter or more, or the need for transfusion of at least. Events were adjudicated by an endpoint committee.

  Randomization up to 24 months

Secondary Outcomes (3)

• Any event from the composite of cardiovascular death, non-fatal myocardial infarction, stent thrombosis, coronary revascularization and stroke

  Randomization up to 24 months

• All cause death

  Randomization up to 24 months

• PLATO-defined any bleeding event

  Randomization up to 24 months

Other Outcomes (4)

• PLATO-defined any minor bleeding event

  Randomization up to 24 months

• PLATO-defined any minimal bleeding event

  Randomization up to 24 months

• Other adverse events

  Randomization up to 24 months

Study Arms (2)

Lower dose ticagrelor

EXPERIMENTAL

Subjects will be treated with ticagrelor 45 mg twice daily in combination with aspirin 100mg once daily.

Drug: Ticagrelor 45 mg; Drug: Aspirin

Standard dose ticagrelor

ACTIVE COMPARATOR

Subjects will be treated with ticagrelor 90 mg twice daily in combination with aspirin 100mg once daily.

Drug: Ticagrelor 90 mg; Drug: Aspirin

Interventions

Ticagrelor 90 mg DRUG

Ticagrelor (AZD6140) 90 mg twice daily dose

Also known as: AZD6140

Standard dose ticagrelor

Ticagrelor 45 mg DRUG

Ticagrelor (AZD6140) 45 mg twice daily dose

Also known as: AZD6140

Lower dose ticagrelor

Aspirin DRUG

Aspirin 100 mg once daily dose

Lower dose ticagrelor; Standard dose ticagrelor

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients admission for coronary artery disease treatment with non-emergency percutaneous intervention with stent deployment
• years≤age≤80 years
• Patients understands the study requirements and the treatment procedures and provided informed consent before the procedure

You may not qualify if:

• Allergy or intolerance to ticagrelor or aspirin
• Need for oral anticoagulation therapy
• Concomitant oral or intravenous therapy with strong inhibitors of Cytochrome P450, family 3, subfamily A (CYP3A), Substrates of CYP3A with narrow therapeutic indices or strong inducers of CYP3A
• Active bleeding, previous history of intracranial hemorrhage, gastrointestinal hemorrhage in the past 6 months and major operation within 30 days
• High risk of bradyarrhythmias
• Severe liver dysfunction and abnormal renal function
• Patient is a woman who is pregnant or nursing
• Unable or unwilling to give written informed consent

Sponsors & Collaborators

• Xiaofan Wu: lead

Study Sites (1)

Xiaofan Wu

Beijing, Beijing Municipality, 100029, China

RECRUITING

MeSH Terms

Conditions

Angina, Unstable; Coronary Artery Disease

Interventions

Ticagrelor; Aspirin

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Xiaofan Wu

  Beijing Anzhen Hospital

  STUDY DIRECTOR

Central Study Contacts

Xiaofan Wu, MD

CONTACT

13370103552; drwuxf@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician

Model Details: Eligible patients were randomly assigned in a 1:1 ratio to receive ticagrelor 90 mg twice daily plus aspirin 100mg once daily or ticagrelor 45 mg twice daily plus aspirin 100mg once daily.

Study Record Dates

• First Submitted: August 5, 2018
• First Posted: August 8, 2018
• Study Start: August 7, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: December 24, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)