Comparing low dose and standard ticagrelor for older patients after heart intervention
A Randomized Controlled sTudy of Low Dose vs Standard tIcaGrelor on Platelet Function After intErvention for Acute Coronary syndRome in Senior Patients
PHASE4 · Shanghai Tong Ren Hospital · NCT04307485
This study is testing whether a lower dose of ticagrelor is just as effective as the standard dose for older patients who have had heart procedures.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 75 Years and up |
| Sex | All |
| Sponsor | Shanghai Tong Ren Hospital (other) |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT04307485 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 senior patients aged 75 and older who have undergone percutaneous coronary intervention for acute coronary syndrome. A total of 40 participants will be randomly assigned to receive either the low or standard dose of ticagrelor along with aspirin for a duration of 12 months. The primary endpoints will be assessed through platelet function tests conducted two months after the intervention, with clinical events monitored over the following year.
Who should consider this trial
Good fit: Ideal candidates are senior patients aged 75 and older who have successfully undergone PCI for acute coronary syndrome.
Not a fit: Patients with active bleeding, known hypersensitivity to 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 older patients with acute coronary syndrome.
How similar studies have performed: While similar studies have explored dosing strategies for antiplatelet therapy, this specific low-dose approach in senior patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Shanghai, Shanghai
- shanghai Tongren hospital — Shanghai, 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.
Conditions: Senior Acute Coronary Syndrome Patients After PCI