Clinical trial NCT06254391: Aspirin Dose Comparison in Elderly PCI Patients: 30mg vs. 75mg in Acute Coronary Syndrome
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Myocardial Infarction
Acute Coronary Syndrome
Keywords: Dual Antiplatelet Therapy
Myocardial Infarction
Acute Coronary Syndrome
Very-low dose aspirin
PCI
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2024-02-12
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Platelet reactivity (ASPI)
timeFrame: 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:
measure: Platelet reactivity (ADP)
timeFrame: 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)
measure: Platelet reactivity (TRAP-6)
timeFrame: 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)
measure: Platelet reactivity (ASPI)
timeFrame: 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)
measure: Bleeding time
timeFrame: Days 7, 14, and 28 of treatment 2 hours after the administration of the ASA dose
measure: PGI2 levels
timeFrame: Measured on days 7, 14, and 28 of treatment, 2 hours after the administration of the ASA dose
measure: TXB2 levels
timeFrame: Days 7, 14, and 28 of treatment, 2 hours before the administration of the next ASA dose, and 2 hours after the ASA dose
Other outcomes:
measure: Safety monitoring
timeFrame: 90th day
Locations:
city: Warsaw
country: Poland
facility: 1st Department and Clinic of Cardiology, Medical University of Warsaw
state: Mazowieckie Voivodenship
Study officials:
affiliation: 1st Department and Clinic of Cardiology, Medical University of Warsaw
name: Mariusz Tomaniak, PhD
role: PRINCIPAL_INVESTIGATOR
References: