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.

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Elderly patients undergoing percutaneous coronary intervention (PCI) face a high risk of both ischemic and hemorrhagic complications necessitating antiplatelet therapy. Previous data indicate that even at a dose of 20-30 mg/day, aspirin (ASA) allows almost complete inhibition of thromboxane (TX) A2 biosynthesis in healthy volunteers. However, ASA at a dose of 30 mg/day has not been evaluated in the acute phase of myocardial infarction or among elderly patients, where it may achieve an optimal balance between bleeding risk and ischemic complications. This randomized study will include 40 patients over 65 years undergoing PCI for acute coronary syndrome (ACS). It compares a new dual antiplatelet therapy (DAPT) strategy consisting of a P2Y12 antagonist (ticagrelor) and ASA at a very low dose of 30 mg/day (n=20) against the current standard treatment (P2Y12 antagonist and ASA at a dose of 75 mg) (n=20) in the control group.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Poland
1st Department and Clinic of Cardiology, Medical University of Warsaw
RECRUITING
Warsaw
Contact Information
Primary
Mariusz Tomaniak, PhD
mariusz.tomaniak@wum.edu.pl
+48 22 599-19-58
Time Frame
Start Date: 2023-07-03
Estimated Completion Date: 2025-07
Participants
Target number of participants: 40
Treatments
Other: Very low-dose aspirin first
Patients will receive ASA 30mg per day (in the morning) for 14 days, followed by ASA 75mg per day (in the morning) for the next 14 days.~All the participants will receive standard maintenance dose of ticagrelor 90mg twice a day as part of the DAPT therapy. All the participants will receive the loading dose of ASA 300mg before the PCI procedure.
Other: Standard low-dose aspirin first
Patients will receive ASA 75mg per day (in the morning) for 14 days, followed by ASA 30mg per day (in the morning) for the next 14 days.~All the participants will receive standard maintenance dose of ticagrelor 90mg twice a day as part of the DAPT therapy. All the participants will receive the loading dose of ASA 300mg before the PCI procedure.
Sponsors
Leads: Medical University of Warsaw

This content was sourced from clinicaltrials.gov

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