- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04307511
A sTudy of Low Dose vs Standard Dose of tIcaGrelor on Platelet Function After intErvention for Acute Coronary syndRome in Diabetes Mellitus Patients (TIGER-diabetes)
April 18, 2024 updated by: Hou Lei, Shanghai Tong Ren Hospital
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
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.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lei Hou, Doctor
- Phone Number: 13564868096
- Email: Dr_houlei@163.com
Study Locations
-
-
-
Shanghai, China, 200336
- Recruiting
- shanghai Tongren hospital
-
Contact:
- Lei Hou, Doctor
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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
|
Aspirin
60mg ticagrelor based DAPT vs 90mg ticagrelor based DAPT vs 90mg ticagrelor monotherapy
|
Active Comparator: standard dose DAPT therapy
treated with ticagrelor 90mg and aspirin 100mg after PCI for 12 months as the standard group
|
Aspirin
60mg ticagrelor based DAPT vs 90mg ticagrelor based DAPT vs 90mg ticagrelor monotherapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
changes of PRI detected by VASP
Time Frame: 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 PRI from baseline (1 months after index PCI) to 2 months after index PCI
|
changes of Maximum Amplitude (MA) detected by TEG
Time Frame: changes of MA from baseline (1 months after index PCI) to 2 months after index PCI
|
Maximum Amplitude (MA) detected by TEG(Thromboelastography)
|
changes of MA from baseline (1 months after index PCI) to 2 months after index PCI
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 20, 2020
Primary Completion (Estimated)
April 30, 2024
Study Completion (Estimated)
May 31, 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)
April 22, 2024
Last Update Submitted That Met QC Criteria
April 18, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Disease
- Diabetes Mellitus
- Syndrome
- Acute Coronary Syndrome
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Cyclooxygenase Inhibitors
- Antipyretics
- Purinergic P2Y Receptor Antagonists
- Purinergic P2 Receptor Antagonists
- Purinergic Antagonists
- Purinergic Agents
- Aspirin
- Ticagrelor
Other Study ID Numbers
- 2020PYN
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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