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

NCT ID: NCT04307485

Last Updated: 2023-10-06

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-10

Study Completion Date

2024-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Senior Acute Coronary Syndrome Patients 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 ticargrelor based 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

90mg ticargrelor based DAPT vs 60mg ticargrelor based DAPT

low dose ticargrelor based DAPT

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

Group Type EXPERIMENTAL

Ticagrelor

Intervention Type DRUG

90mg ticargrelor based DAPT vs 60mg ticargrelor based DAPT

Interventions

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Ticagrelor

90mg ticargrelor based DAPT vs 60mg ticargrelor based DAPT

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Tong Ren Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hou Lei

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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shanghai Tongren hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Lei Hou, Doctor

Role: CONTACT

13564868096

Facility Contacts

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Lei Hou, Doctor

Role: primary

Other Identifiers

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2020HL

Identifier Type: -

Identifier Source: org_study_id

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