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This is a multi-center, prospective, randomized, single-blind, investigator initiated, pharmacodynamic study of parallel design, performed at 3 institutions (Patras University Hospital; Evangelismos Athens General Hospital; Gennimatas Athens General Hospital).
Patients with ST elevation myocardial infarction (symptom onset < 12 hours), undergoing primary percutaneous coronary intervention, who are antiplatelet naïve (Group A) or present high residual PR (defined as PRU ≥ 208) immediately before primary percutaneous coronary intervention, will be randomized after informed consent, in a 1:1 ratio to either:
Ticagrelor 180mg loading dose (LD), followed by a 90mg x2 maintenance dose (MD )starting 12±6 hours post LD Or Ticagrelor 360mg loading dose (LD), followed by a 90mg x2 maintenance dose (MD) starting 12±6 hours post LD Platelet reactivity assessment will be performed at randomization (Hour 0) and at 0.5, 1, 2, 4 hours after randomization, using the VerifyNow assay, in platelet reactivity units (PRU).
Documentation of major adverse cardiac events (death, myocardial infarction, stroke, urgent revascularization procedure with PCI or CABG) and bleeding (according to Bleeding Academic Research Consortium criteria) will be performed until patient's discharge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ticagrelor 180mg loading dose | Active Comparator | Ticagrelor 180mg loading dose |
|
| Ticagrelor 360mg loading dose | Experimental | Ticagrelor 360mg loading dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ticagrelor | Drug | Ticagrelor 360mg loading dose immediately pre prior percutaneous coronary intervention 360mg loading dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| platelet reactivity at 1 hour post randomization in Group A, between the 2 treatment arms. | platelet reactivity at 1 hour post randomization in Group A, between the 2 treatment arms. | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| 1. Platelet reactivity at 1 hour post randomization in Group B, between the 2 treatment arms. | 1. Platelet reactivity at 1 hour post randomization in Group B, between the 2 treatment arms. | 1 hour |
| 2. Platelet reactivity at 0.5 hour post randomization between the 2 treatment arms separately for Group A and B |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Dimitrios Alexopoulos, MD | University Hospital of Patras | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiology Department Patras University Hospital | Rio | Achaia | 26500 | Greece |
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| Ticagrelor | Drug | Ticagrelor 180mg loading dose 180mg loading dose |
|
Platelet reactivity at 0.5 hour post randomization between the 2 treatment arms separately for Group A and B |
| 0.5 hour |
| Platelet reactivity at 2 hours post randomization between the 2 treatment arms separately for Group A and B | Platelet reactivity at 2 hours post randomization between the 2 treatment arms separately for Group A and B | 2 hours |
| Platelet reactivity at 4 hours post randomization between the 2 treatment arms separately for Group A and B | Platelet reactivity at 4 hours post randomization between the 2 treatment arms separately for Group A and B | 4 hours |
| 3. High on treatment platelet reactivity (HTPR) rates (≥208 PRU) at 0.5 hour post randomization between the 2 treatment arms, separately for Group A and B | High on treatment platelet reactivity (HTPR) rates (≥208 PRU) at 0.5 hour post randomization between the 2 treatment arms, separately for Group A and B | 0.5 hour |
| High on treatment platelet reactivity (HTPR) rates (≥208 PRU) at 1 hour post randomization between the 2 treatment arms, separately for Group A and B | High on treatment platelet reactivity (HTPR) rates (≥208 PRU) at 1 hour post randomization between the 2 treatment arms, separately for Group A and B | 1 hour |
| High on treatment platelet reactivity (HTPR) rates (≥208 PRU) at 2 hours post randomization between the 2 treatment arms, separately for Group A and B | High on treatment platelet reactivity (HTPR) rates (≥208 PRU) at 2 hours post randomization between the 2 treatment arms, separately for Group A and B | 2 hours |
| High on treatment platelet reactivity (HTPR) rates (≥208 PRU) at 4 hours post randomization between the 2 treatment arms, separately for Group A and B | High on treatment platelet reactivity (HTPR) rates (≥208 PRU) at 4 hours post randomization between the 2 treatment arms, separately for Group A and B | 4 hours |
| Occurrence of any 5-day bleeding event (BARC Types 1-5) | Occurrence of any 5-day bleeding event (BARC Types 1-5) | 5 days |
| Occurrence of 5-day MACEs | Occurrence of 5-day MACEs | 5 days |
| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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| ID | Term |
|---|---|
| D000077486 | Ticagrelor |
| ID | Term |
|---|---|
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
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