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

NCT06254391 | Recruiting Phase 2 DMC

• 1 other identifier: LowASA-PCI
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

Dual Antiplatelet Therapy; Myocardial Infarction; Acute Coronary Syndrome; Very-low dose aspirin; PCI

Outcome Measures

Primary Outcomes (1)

• Platelet reactivity (ASPI)

  Comparison of platelet reactivity dependent on arachidonic acid (ASPI test) in low-dose ASA therapy, assessed in impedance aggregometry in regards to group treated with DAPT with standard ASA 75mg dose after 14 days of therapy.

  14th day of treatment, 2h before ASA 30mg dose (through effect), and 2h after ASA 30mg dose (peak effect), in regards to group treated with DAPT with standard ASA 75mg dose after 14 days of therapy

Secondary Outcomes (6)

• Platelet reactivity (ADP)

  Days 7, 14, and 28 of treatment, 2 hours before the administration of the next ASA dose (pre-dose - representing the trough effect), and 2 hours after the ASA dose (post-dose - representing the peak effect)

• Platelet reactivity (TRAP-6)

  Days 7, 14, and 28 of treatment, 2 hours before the administration of the next ASA dose (pre-dose - representing the trough effect), and 2 hours after the ASA dose (post-dose - representing the peak effect)

• Platelet reactivity (ASPI)

  Days 7, and 28 of treatment, 2 hours before the administration of the next ASA dose (pre-dose - representing the trough effect), and 2 hours after the ASA dose (post-dose - representing the peak effect)

• Bleeding time

  Days 7, 14, and 28 of treatment 2 hours after the administration of the ASA dose

• PGI2 levels

  Measured on days 7, 14, and 28 of treatment, 2 hours after the administration of the ASA dose

Other Outcomes (1)

• Safety monitoring

  90th day

Study Arms (2)

Very low-dose aspirin first

OTHER

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.

Drug: Low-dose aspirin

Standard low-dose aspirin first

OTHER

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.

Drug: Low-dose aspirin

Interventions

Low-dose aspirin DRUG

Implementation of low-dose aspirin (30 mg)

Standard low-dose aspirin first; Very low-dose aspirin first

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

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

Warsaw, Mazowieckie Voivodenship, 02-097, Poland

RECRUITING

MeSH Terms

Conditions

Myocardial Infarction; Acute Coronary Syndrome

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Mariusz Tomaniak, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariusz Tomaniak, PhD

CONTACT

+48 22 599-19-58; mariusz.tomaniak@wum.edu.pl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Tomaniak Mariusz MD PhD Assoc. Prof.

Model Details: After collecting basic clinical information about the patients, patients undergoing percutaneous coronary intervention (PCI) due to acute coronary syndrome (within 24-48 hours after the procedure) will be randomized in a 1:1 scheme using the mobile application "Randomizer for Clinical Trial" (Medsharing, France) to one of the two arms of the study receiving ticagrelor at a maintenance dose of 90 mg twice daily, in which the following treatment sequence will be used (open-label crossover design): 1. Aspirin (ASA) 30 mg once daily (morning) for 14 days followed by ASA 75 mg once daily (morning) for 14 days or 2. ASA 75 mg once daily (morning) for 14 days, then ASA 30 mg once daily (morning) for 14 days. All patients will receive a loading dose of aspirin 300 mg before PCI

Study Record Dates

• First Submitted: February 2, 2024
• First Posted: February 12, 2024
• Study Start: July 3, 2023
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: February 12, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)