Comparing low-dose aspirin in elderly patients after heart procedures
Very Low-dose Aspirin (30mg) vs. Standard Low-dose Aspirin (75mg) Among Patients Aged 65 Years or Above Undergoing PCI for Acute Coronary Syndrome: an Open-label Randomized Crossover Design Trial.
This study tests if a lower dose of aspirin can safely help older patients after heart procedures without causing too much bleeding.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Medical University of Warsaw Academic / other |
| Drugs / interventions | abciximab |
| Locations | 1 site (Warsaw, Mazowieckie Voivodenship) |
| Trial ID | NCT06254391 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a very low dose of aspirin (30 mg) compared to the standard dose (75 mg) in elderly patients over 65 years who are undergoing percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS). The study aims to determine if the lower dose can provide sufficient antiplatelet effects while minimizing the risk of bleeding complications. It involves a randomized approach with 40 participants, half receiving the lower dose and half receiving the standard treatment. The trial focuses on patients with confirmed myocardial necrosis markers and aims to optimize dual antiplatelet therapy in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates are elderly patients over 65 years who have experienced acute coronary syndrome and are undergoing PCI.
Not a fit: Patients with conditions requiring different antiplatelet therapy or those with a history of stent thrombosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer and more effective antiplatelet therapy for elderly patients undergoing PCI.
How similar studies have performed: While similar studies have explored low-dose aspirin, this specific approach in elderly PCI patients is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * age above 65 years * acute coronary syndrome (ACS) * positive results for myocardial necrosis markers (troponins) * undergoing successful coronary angioplasty with stent implantation within the last 24-48 hours before enrollment in the study * dual antiplatelet therapy (DAPT) containing ticagrelor Exclusion Criteria: * indications other than ACS and PCI for DAPT use * history of stent thrombosis during the course of DAPT * planned subsequent coronary artery revascularization * planned surgery requiring suspension or interruption of DAPT * planned discontinuation of ASA or P2Y12 antagonist during the study * use of doses other than 75 mg ASA once daily or non-use of a P2Y12 inhibitor - intake of diuretic drugs (e.g., loop diuretics, thiazides, potassium-sparing drugs) * intake or planned intake of oral anticoagulants, parenteral antithrombotic therapy (e.g., unfractionated heparin, low molecular weight heparin, bivalirudin), glycoprotein IIb/IIIa inhibitors (e.g., abciximab, tirofiban), fibrinolytic agents (e.g., tissue plasminogen activator), or nonsteroidal anti-inflammatory drugs * history of acute or chronic liver disease; severe kidney disease requiring dialysis; pregnancy; comorbidities associated with a predicted life expectancy of less than 1 year * any other condition deemed by the investigator to impact hemostasis, coagulation, bleeding risk, or the ability to adhere to the study protocol; receiving a strong inhibitor of cytochrome P450 3A, simvastatin or lovastatin at doses greater than 40 mg per day, a narrow therapeutic index cytochrome P450 3A substrate (e.g., cyclosporine or quinidine), or a strong inducer of cytochrome P450 3A (e.g., rifampin, rifabutin, phenytoin, carbamazepine, phenobarbital) * hemodynamic instability; clinical condition preventing obtaining informed consent.
Where this trial is running
Warsaw, Mazowieckie Voivodenship
- 1st Department and Clinic of Cardiology, Medical University of Warsaw — Warsaw, Mazowieckie Voivodenship, Poland (Recruiting)
Study contacts
- Principal investigator: Mariusz Tomaniak, PhD — 1st Department and Clinic of Cardiology, Medical University of Warsaw
- Study coordinator: Mariusz Tomaniak, PhD
- Email: mariusz.tomaniak@wum.edu.pl
- Phone: +48 22 599-19-58
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.