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A Study of Low Dose vs Standard Ticagrelor on Platelet Function After Intervention for Acute Coronary Syndrome in Senior Patients

Sponsor
Shanghai Tong Ren Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04307485
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
27.7
Anticipated Duration (Months)
1.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized Controlled sTudy of Low Dose vs Standard tIcaGrelor on Platelet Function After intErvention for Acute Coronary syndRome in Senior Patients
Actual Study Start Date :
Mar 10, 2020
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Jul 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: standard dose ticargrelor based DAPT therapy

treated with ticagrelor 90mg and aspirin 100mg after PCI for 12 months as the standard group

Drug: Ticagrelor
90mg ticargrelor based DAPT vs 60mg ticargrelor based DAPT
Experimental: low dose ticargrelor based DAPT

treated with ticagrelor 60mg plus aspirin 100 mg for 11 months after one month standard DAPT treatment

Drug: Ticagrelor
90mg ticargrelor based DAPT vs 60mg ticargrelor based DAPT

Outcome Measures

Primary Outcome Measures

  1. changes of PRI detected by VASP methods [changes of PRI from baseline (4weeks after index PCI) to 8 and 12 weeks after index PCI]

    platelet reactivity index (PRI) detected by VASP (Vasodilator Stimulated

  2. changes of Maximum Amplitude (MA) detected by TEG [changes of MA from baseline (4weeks after index PCI) to 8 and 12 weeks after index PCI]

    Maximum Amplitude (MA) detected by TEG(Thromboelastography)

Eligibility Criteria

Criteria

Ages Eligible for Study:
75 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 shanghai Tongren hospital Shanghai Shanghai China 200336

Sponsors and Collaborators

  • Shanghai Tong Ren Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hou Lei, Clinical Professor, Shanghai Tong Ren Hospital
ClinicalTrials.gov Identifier:
NCT04307485
Other Study ID Numbers:
  • 2020HL
First Posted:
Mar 13, 2020
Last Update Posted:
Mar 15, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Acute Coronary Syndrome
Syndrome
Ticagrelor

Study Results

No Results Posted as of Mar 15, 2022