A Study of Low Dose vs Standard Ticagrelor on Platelet Function After Intervention for Acute Coronary Syndrome in Senior Patients
Primary Purpose
Senior Acute Coronary Syndrome Patients After PCI
Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Ticagrelor
Sponsored by
About this trial
This is an interventional treatment trial for Senior Acute Coronary Syndrome Patients After PCI
Eligibility Criteria
Inclusion Criteria:
1.Subject must be at least 75 years of age 2 Patients should have undergone successful percutaneous coronary intervention with drug-eluting stent for acute coronary syndrome 3.Subject understand the study requirements and the treatment procedures and provided informed consent before the procedure
Exclusion Criteria:
- Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study
- Active bleeding
- Known hypersensitivity or contraindication to study medications
- Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study
- Non-cardiac co-morbid conditions are present with life expectancy <2 year or that may result in protocol non-compliance (per site investigator's medical judgment).
- Subjects with Cerebral hemorrhage history
- Subjects with stroke history in half a year
- subjects with active malignant tumor
- subjects with whom oral anticoagulants are needed
- Other conditions which the investigators think not applicable to the study.
Sites / Locations
- shanghai Tongren hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
standard dose ticargrelor based DAPT therapy
low dose ticargrelor based DAPT
Arm Description
treated with ticagrelor 90mg and aspirin 100mg after PCI for 12 months as the standard group
treated with ticagrelor 60mg plus aspirin 100 mg for 11 months after one month standard DAPT treatment
Outcomes
Primary Outcome Measures
changes of PRI detected by VASP methods
platelet reactivity index (PRI) detected by VASP (Vasodilator Stimulated
changes of Maximum Amplitude (MA) detected by TEG
Maximum Amplitude (MA) detected by TEG(Thromboelastography)
Secondary Outcome Measures
Full Information
NCT ID
NCT04307485
First Posted
March 8, 2020
Last Updated
October 5, 2023
Sponsor
Shanghai Tong Ren Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04307485
Brief Title
A Study of Low Dose vs Standard Ticagrelor on Platelet Function After Intervention for Acute Coronary Syndrome in Senior Patients
Official Title
A Randomized Controlled sTudy of Low Dose vs Standard tIcaGrelor on Platelet Function After intErvention for Acute Coronary syndRome in Senior Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 10, 2020 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Tong Ren Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
In this study, the investigates try to confirm our hypothesis that low dose ticagrelor(60mg) had similar anti-platelets function compared with the standard dose ticagrelor in senior (no less than 75 years old)acute coronary syndrome patients . Totally 40 senior ACS patients will be divided into 2 groups randomly one month after PCI . Group 1 will be treated with ticagrelor 90mg and aspirin 100mg after PCI for 12 months as the standard group; Group 2 will be treated with ticagrelor 60mg plus aspirin 100 mg for 11 months after one month standard DAPT treatment. The platelets function will be tested in VASP and TEG methods 2 months after PCI as the primary endpoints.The clinical events will be observed 12 months after PCI.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Senior Acute Coronary Syndrome Patients After PCI
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
standard dose ticargrelor based DAPT therapy
Arm Type
Active Comparator
Arm Description
treated with ticagrelor 90mg and aspirin 100mg after PCI for 12 months as the standard group
Arm Title
low dose ticargrelor based DAPT
Arm Type
Experimental
Arm Description
treated with ticagrelor 60mg plus aspirin 100 mg for 11 months after one month standard DAPT treatment
Intervention Type
Drug
Intervention Name(s)
Ticagrelor
Intervention Description
90mg ticargrelor based DAPT vs 60mg ticargrelor based DAPT
Primary Outcome Measure Information:
Title
changes of PRI detected by VASP methods
Description
platelet reactivity index (PRI) detected by VASP (Vasodilator Stimulated
Time Frame
changes of PRI from baseline (4weeks after index PCI) to 8 and 12 weeks after index PCI
Title
changes of Maximum Amplitude (MA) detected by TEG
Description
Maximum Amplitude (MA) detected by TEG(Thromboelastography)
Time Frame
changes of MA from baseline (4weeks after index PCI) to 8 and 12 weeks after index PCI
10. Eligibility
Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1.Subject must be at least 75 years of age 2 Patients should have undergone successful percutaneous coronary intervention with drug-eluting stent for acute coronary syndrome 3.Subject understand the study requirements and the treatment procedures and provided informed consent before the procedure
Exclusion Criteria:
Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study
Active bleeding
Known hypersensitivity or contraindication to study medications
Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study
Non-cardiac co-morbid conditions are present with life expectancy <2 year or that may result in protocol non-compliance (per site investigator's medical judgment).
Subjects with Cerebral hemorrhage history
Subjects with stroke history in half a year
subjects with active malignant tumor
subjects with whom oral anticoagulants are needed
Other conditions which the investigators think not applicable to the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lei Hou, Doctor
Phone
13564868096
Email
Dr_houlei@163.com
Facility Information:
Facility Name
shanghai Tongren hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200336
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lei Hou, Doctor
12. IPD Sharing Statement
Learn more about this trial
A Study of Low Dose vs Standard Ticagrelor on Platelet Function After Intervention for Acute Coronary Syndrome in Senior Patients
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