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

NCT04307511 | Recruiting Phase 4

• 1 other identifier: 2020PYN
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndrome Patients With Diabetes After PCI

Outcome Measures

Primary Outcomes (2)

• changes of PRI detected by VASP

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

  changes of PRI from baseline (1 months after index PCI) to 2 months after index PCI

• changes of Maximum Amplitude (MA) detected by TEG

  Maximum Amplitude (MA) detected by TEG(Thromboelastography)

  changes of MA from baseline (1 months after index PCI) to 2 months after index PCI

Study Arms (2)

low dose DAPT therapy

EXPERIMENTAL

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; Drug: Aspirin

standard dose DAPT therapy

ACTIVE COMPARATOR

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

Drug: Ticagrelor; Drug: Aspirin

Interventions

Ticagrelor DRUG

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

low dose DAPT therapy; standard dose DAPT therapy

Aspirin DRUG

Aspirin

low dose DAPT therapy; standard dose DAPT therapy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Tong Ren Hospital: lead

Study Sites (1)

shanghai Tongren hospital

Shanghai, 200336, China

RECRUITING

MeSH Terms

Interventions

Ticagrelor; Aspirin

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Lei Hou, Doctor

CONTACT

13564868096; Dr_houlei@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: March 8, 2020
• First Posted: March 13, 2020
• Study Start: April 20, 2020
• Primary Completion: April 30, 2024
• Study Completion: May 31, 2024
• Last Updated: April 22, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)