Aspirin Dose Comparison in Elderly PCI Patients: 30mg vs. 75mg in Acute Coronary Syndrome

NCT ID: NCT06254391

Last Updated: 2024-02-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-03
• Study Completion Date: 2025-07-31

Brief 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.

Conditions

Myocardial Infarction; Acute Coronary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Low-dose aspirin

Intervention Type: DRUG

Implementation of low-dose aspirin (30 mg)

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.

Group Type: OTHER

Low-dose aspirin

Intervention Type: DRUG

Implementation of low-dose aspirin (30 mg)

Interventions

Low-dose aspirin

Implementation of low-dose aspirin (30 mg)

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of Warsaw

OTHER

Sponsor Role: lead

Responsible Party

Mariusz Tomaniak

Tomaniak Mariusz MD PhD Assoc. Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mariusz Tomaniak, PhD

Role: PRINCIPAL_INVESTIGATOR

1st Department and Clinic of Cardiology, Medical University of Warsaw

Locations

1st Department and Clinic of Cardiology, Medical University of Warsaw

Warsaw, Mazowieckie Voivodenship, Poland

Site Status: RECRUITING

Countries

Poland

Central Contacts

Mariusz Tomaniak, PhD

Role: CONTACT

mariusz.tomaniak@wum.edu.pl

+48 22 599-19-58

Facility Contacts

Mariusz Tomaniak, PhD

Role: primary

mariusz.tomaniak@wum.edu.pl

+48 22 599-19-58

Other Identifiers

LowASA-PCI

Identifier Type: -

Identifier Source: org_study_id