Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: NCT03620760
Recruitment Status : Recruiting
First Posted : August 8, 2018
Last Update Posted : December 24, 2018
Sponsor:
Information provided by (Responsible Party):
Xiaofan Wu, Beijing Anzhen Hospital

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.

Condition or disease Intervention/treatment Phase
Unstable Angina Pectoris Coronary Stent Implantation Drug: Ticagrelor 90 mg Drug: Ticagrelor 45 mg Drug: Aspirin Phase 4

Detailed Description:
This is a prospective, single center, randomized, parallel-group trial designed to evaluate the efficacy and safety of low dose ticagrelor on a background of aspirin for patients treated with non-urgent coronary stent implantation. 2036 subjects will be enrolled. All patients will receive treatment with aspirin and a P2Y12 inhibitor for 3 months after the index procedure. At 3 months, eligible patients were then randomly assigned in a 1:1 ratio to receive a standard dose ticagrelor 90 mg bid or a lower dose ticagrelor 45 mg bid in addition to aspirin 100mg. The primary efficacy end points are the event rate of the composite of cardiovascular death, non-fatal myocardial infarction, stent thrombosis, coronary revascularization and stroke at 24 months. The primary safety end point is the incidence of PLATO major bleeding at 24 months.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2036 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomised, Open-labeled, Parallel Group Study to Assess the Efficacy and Safety of Low Dose Ticagrelor Compared With Standard Dose Ticagrelor in Patients With Unstable Angina Pectoris After Drug Eluting Stent Implantation
Actual Study Start Date : August 7, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina

Arm Intervention/treatment
Experimental: Lower dose ticagrelor
Subjects will be treated with ticagrelor 45 mg twice daily in combination with aspirin 100mg once daily.
Drug: Ticagrelor 45 mg
Ticagrelor (AZD6140) 45 mg twice daily dose
Other Name: AZD6140

Drug: Aspirin
Aspirin 100 mg once daily dose

Active Comparator: Standard dose ticagrelor
Subjects will be treated with ticagrelor 90 mg twice daily in combination with aspirin 100mg once daily.
Drug: Ticagrelor 90 mg
Ticagrelor (AZD6140) 90 mg twice daily dose
Other Name: AZD6140

Drug: Aspirin
Aspirin 100 mg once daily dose




Primary Outcome Measures :
  1. Incidence of major adverse cardiovascular and cerebrovascular events (MACCEs) and major bleeding event [ Time Frame: Randomization up to 24 months ]

    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.



Secondary Outcome Measures :
  1. Any event from the composite of cardiovascular death, non-fatal myocardial infarction, stent thrombosis, coronary revascularization and stroke [ Time Frame: Randomization up to 24 months ]
    Participants with any event from the composite of cardiovascular death, non-fatal MI, stent thrombosis, coronary revascularization and stroke. ITT analysis of intent for invasive management population. Events were adjudicated by an endpoint committee.

  2. All cause death [ Time Frame: Randomization up to 24 months ]
    Participants with all cause death. ITT analysis of whole population. Events were adjudicated by an endpoint committee.

  3. PLATO-defined any bleeding event [ Time Frame: Randomization up to 24 months ]
    Participants with any other bleeding events (minor bleeding or minimal bleeding) as defined by the PLATO. Events were adjudicated by an endpoint committee.


Other Outcome Measures:
  1. PLATO-defined any minor bleeding event [ Time Frame: Randomization up to 24 months ]
    To compare two intensities of ticagrelor therapy on minor bleeding event as any bleeding requiring medical intervention but not meeting the criteria for major bleeding. Events were adjudicated by an endpoint committee.

  2. PLATO-defined any minimal bleeding event [ Time Frame: Randomization up to 24 months ]
    To compare two intensities of ticagrelor therapy on minimal bleeding event as all other bleeding (eg, bruising, bleeding gums, oozing from injection site) not requiring intervention or treatment. Events were adjudicated by an endpoint committee.

  3. Other adverse events [ Time Frame: Randomization up to 24 months ]
    To compare two intensities of ticagrelor therapy on other adverse events including dyspnea or bradyarrhythmia. Events were adjudicated by an endpoint committee.

  4. Experiment examination [ Time Frame: Randomization up to 24 months ]
    To compare two intensities of ticagrelor therapy on increase of serum uric acid or creatinine. Events were adjudicated by an endpoint committee.



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 to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

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): NCT03620760


Contacts
Layout table for location contacts
Contact: Xiaofan Wu, MD 13370103552 drwuxf@163.com

Locations
Layout table for location information
China, Beijing
Xiaofan Wu Recruiting
Beijing, Beijing, China, 100029
Contact: Xiaofan Wu, Master         
Sponsors and Collaborators
Xiaofan Wu
Investigators
Layout table for investigator information
Study Director: Xiaofan Wu Beijing Anzhen Hospital

Layout table for additonal information
Responsible Party: Xiaofan Wu, Chief Physician, Beijing Anzhen Hospital
ClinicalTrials.gov Identifier: NCT03620760     History of Changes
Other Study ID Numbers: 2018-2-1064
First Posted: August 8, 2018    Key Record Dates
Last Update Posted: December 24, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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 Xiaofan Wu, Beijing Anzhen Hospital:
Unstable Angina
Stent
Ticagrelor
Platelet aggregation
Percutaneous Coronary Intervention
Coronary Artery Disease
Major Adverse Cardiovascular and Cerebrovascular Events
Bleeding Events

Additional relevant MeSH terms:
Layout table for MeSH terms
Myocardial Ischemia
Angina Pectoris
Angina, Unstable
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Aspirin
Ticagrelor
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists