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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
Shanghai Tong Ren Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Senior Acute Coronary Syndrome Patients After PCI

Eligibility Criteria

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

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:

  1. Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study
  2. Active bleeding
  3. Known hypersensitivity or contraindication to study medications
  4. Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study
  5. 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).
  6. Subjects with Cerebral hemorrhage history
  7. Subjects with stroke history in half a year
  8. subjects with active malignant tumor
  9. subjects with whom oral anticoagulants are needed
  10. 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

First Posted
March 8, 2020
Last Updated
October 5, 2023
Sponsor
Shanghai Tong Ren Hospital
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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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