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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-dose aspirin | Drug | Implementation of low-dose aspirin (30 mg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Platelet reactivity (ADP) | Comparison of platelet reactivity dependent on ADP (ADP test) in low-dose ASA therapy, assessed in impedance aggregometry in regards to the group treated with DAPT with standard ASA 75mg dose and level changes in individual patients. | 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 | Description | Time Frame |
|---|---|---|
| Safety monitoring | Clinical endpoints (safety monitoring) will include an assessment of the composite endpoint comprising adverse cardiovascular events (MACE): death, myocardial infarction, stroke, and non-elective coronary artery revascularization within 3 months of PCI. The frequency of bleeding complications (BARC 1,2,3,4, or 5), and the frequency of confirmed and probable stent thrombosis defined by the Academic Research Consortium will also be evaluated. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mariusz Tomaniak, PhD | Contact | +48 22 599-19-58 | mariusz.tomaniak@wum.edu.pl |
| Name | Affiliation | Role |
|---|---|---|
| Mariusz Tomaniak, PhD | 1st Department and Clinic of Cardiology, Medical University of Warsaw | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1st Department and Clinic of Cardiology, Medical University of Warsaw | Recruiting | Warsaw | Mazowieckie Voivodenship | 02-097 | Poland |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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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):
All patients will receive a loading dose of aspirin 300 mg before PCI
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| Platelet reactivity (TRAP-6) | Comparison of platelet reactivity dependent on TRAP-6 protein activating the thrombin receptor (TRAP test) in low-dose ASA therapy, assessed in impedance aggregometry in regards to group treated with DAPT with standard ASA 75mg dose and level changes in individual patients. | 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) | 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 and level changes in individual patients. | 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 | Comparison of bleeding time (assessed with lancet method) between two groups (ASA 30mg and ASA 75mg) and among the individual patients. | Days 7, 14, and 28 of treatment 2 hours after the administration of the ASA dose |
| PGI2 levels | Comparison of PGI2 concentration in urine between two groups (ASA 30mg and ASA 75mg) and among the individual patients. | Measured on days 7, 14, and 28 of treatment, 2 hours after the administration of the ASA dose |
| TXB2 levels | Comparison of TXB2 concentration between two groups (ASA 30mg and ASA 75mg) and among the individual patients. | Days 7, 14, and 28 of treatment, 2 hours before the administration of the next ASA dose, and 2 hours after the ASA dose |
| 90th day |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |