Comparing low dose and standard dose ticagrelor for heart patients with diabetes
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
This study is testing whether a lower dose of ticagrelor can work just as well as the standard dose for heart patients with diabetes who have had a procedure to open blocked arteries.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Shanghai Tong Ren Hospital Academic / other |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT04307511 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of a low dose of ticagrelor (60mg) compared to the standard dose (90mg) in patients with diabetes who have undergone percutaneous coronary intervention (PCI) for acute coronary syndrome. A total of 40 participants will be randomly assigned to receive either the low dose or standard dose of ticagrelor along with aspirin for a specified duration. The primary endpoints will focus on measuring platelet function using VASP and TEG methods at one and two months post-PCI, with clinical events monitored over a 12-month period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 90 who have diabetes and have successfully undergone PCI for acute coronary syndrome.
Not a fit: Patients with active bleeding, known hypersensitivity to the study medications, or significant non-cardiac co-morbid conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and equally effective treatment option for patients with diabetes undergoing PCI.
How similar studies have performed: Other studies have explored similar dosing strategies for antiplatelet therapy, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Subject must be at least 18 years of age and less than 90 years old 2. Patients should have undergone successful percutaneous coronary intervention with drug-eluting stent for acute coronary syndrome with diabetes mellitus. 3. Subject understand the study requirements and the treatment procedures and 4. 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.
Where this trial is running
Shanghai
- shanghai Tongren hospital — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Lei Hou, Doctor
- Email: Dr_houlei@163.com
- Phone: 13564868096
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.