A sTudy of Low Dose vs Standard Dose of tIcaGrelor on Platelet Function After intErvention for Acute Coronary syndRome in Diabetes Mellitus Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-20

Study Completion Date

2024-05-31

Brief Summary

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In this study, the investigates try to confirm the hypothesis that low dose ticagrelor(60mg) had similar anti-platelets function compared with the standard dose ticagrelor in acute coronary syndrome patients with diabetes. Totally 40 ACS patients with diabetes will be divided into 2 groups randomly after PCI for one month. Group 1 will be treated with ticagrelor 90mg and aspirin 100mg after PCI for 12 months as the standard group; Group2 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 at 1 and 2 months after PCI as the primary endpoints.The clinical events will be observed 12 months after PCI.

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Detailed Description

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Conditions

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Acute Coronary Syndrome Patients With Diabetes After PCI

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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standard dose DAPT therapy

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

Group Type ACTIVE_COMPARATOR

Ticagrelor

Intervention Type DRUG

60mg ticagrelor based DAPT vs 90mg ticagrelor based DAPT vs 90mg ticagrelor monotherapy

Aspirin

Intervention Type DRUG

Aspirin

low dose DAPT therapy

treated with ticagrelor 60mg plus aspirin 100 mg for 11 months after one month standard DAPT(ticagrelor 90mg plus aspirin 100 mg )treatment

Group Type EXPERIMENTAL

Ticagrelor

Intervention Type DRUG

60mg ticagrelor based DAPT vs 90mg ticagrelor based DAPT vs 90mg ticagrelor monotherapy

Aspirin

Intervention Type DRUG

Aspirin

Interventions

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Ticagrelor

60mg ticagrelor based DAPT vs 90mg ticagrelor based DAPT vs 90mg ticagrelor monotherapy

Intervention Type DRUG

Aspirin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Subject must be at least 18 years of age and less than 90 years old
2. Patients should have undergone successful percutaneous coronary intervention with drug-eluting stent for acute coronary syndrome with diabetes mellitus.
3. Subject understand the study requirements and the treatment procedures and
4. 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No