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

A Randomized Controlled sTudy of Low Dose vs Standard tIcaGrelor on Platelet Function After intErvention for Acute Coronary syndRome in Senior Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Senior Acute Coronary Syndrome Patients After PCI
• Intervention / Treatment: Drug: Ticagrelor

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Lei Hou, Doctor; Phone Number: 13564868096; Email: Dr_houlei@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200336
      • Recruiting
      • Shanghai Tongren Hospital
      • Contact: Lei Hou, doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 71 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes of PRI detected by VASP methods	platelet reactivity index (PRI) detected by VASP (Vasodilator Stimulated	changes of PRI from baseline (4weeks after index PCI) to 8 and 12 weeks after index PCI
changes of Maximum Amplitude (MA) detected by TEG	Maximum Amplitude (MA) detected by TEG(Thromboelastography)	changes of MA from baseline (4weeks after index PCI) to 8 and 12 weeks after index PCI

Collaborators and Investigators

• Sponsor: Shanghai Tong Ren Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2020
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: March 8, 2020
• First Submitted That Met QC Criteria: March 12, 2020
• First Posted (Actual): March 13, 2020

Study Record Updates

• Last Update Posted (Actual): October 6, 2023
• Last Update Submitted That Met QC Criteria: October 5, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Syndrome; Acute Coronary Syndrome; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Ticagrelor
• Other Study ID Numbers: 2020HL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No