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

Sponsor

Shanghai Tong Ren Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04307511

Collaborator

(none)

Enrollment

Location

Arms

27.4

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Coronary Syndrome Patients With Diabetes After PCI	Drug: Ticagrelor Drug: Aspirin	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 Dose of tIcaGrelor on Platelet Function After intErvention for Acute Coronary syndRome in Diabetes Mellitus Patients

Actual Study Start Date :

Apr 20, 2020

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Aug 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Drug: Ticagrelor 60mg ticagrelor based DAPT vs 90mg ticagrelor based DAPT vs 90mg ticagrelor monotherapy Drug: Aspirin Aspirin
Active Comparator: standard dose DAPT therapy treated with ticagrelor 90mg and aspirin 100mg after PCI for 12 months as the standard group	Drug: Ticagrelor 60mg ticagrelor based DAPT vs 90mg ticagrelor based DAPT vs 90mg ticagrelor monotherapy Drug: Aspirin Aspirin

Arm

Intervention/Treatment

Experimental: 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

Drug: Ticagrelor

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

Drug: Aspirin

Aspirin

Active Comparator: standard dose DAPT therapy

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

Drug: Ticagrelor

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

Drug: Aspirin

Aspirin

Outcome Measures

Primary Outcome Measures

changes of PRI detected by VASP [changes of PRI from baseline (1 months after index PCI) to 2 months after index PCI]
platelet reactivity index (PRI) detected by VASP (Vasodilator Stimulated Phosphoprotein) Phosphoprotein)
changes of Maximum Amplitude (MA) detected by TEG [changes of MA from baseline (1 months after index PCI) to 2 months after index PCI]
Maximum Amplitude (MA) detected by TEG(Thromboelastography)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Subject must be at least 18 years of age and less than 90 years old
Patients should have undergone successful percutaneous coronary intervention with drug-eluting stent for acute coronary syndrome with diabetes mellitus.
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	shanghai Tongren hospital	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:

NCT04307511

Other Study ID Numbers:

2020PYN

First Posted:

Mar 13, 2020

Last Update Posted:

Mar 15, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Acute Coronary Syndrome

Study Results

No Results Posted as of Mar 15, 2022