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| Name | Class |
|---|---|
| KCRI | OTHER |
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REL-0609 trial's hypothesis is that repeated loading doses of clopidogrel (600 mg) administration in addition to high dose of clopidogrel continuous therapy (150 mg/day) results in higher inhibition of the platelets' aggregation in patients with myocardial infarction undergoing interventional treatment comparing to the standard therapy. Such treatment strategy will not cause increased risk of bleeding complications. In many trials treatment with to repeated loading doses of clopidogrel together with high dose of clopidogrel continuous therapy resulted in: MACE reduction, improvement of the long term therapy results, lower risk of ischemic complications. Currently, data regarding to the results of the above treatment are still limited.
The objectives of the study is:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clopidogrel - Repeated Loading Dose | Experimental | repeated loading dose of clopidogrel (600 mg) in addition to high dose of clopidogrel continuous therapy for 30 days (150 mg/day) |
|
| Clopidogrel - standard of care | Active Comparator | no repeated loading dose of clopidogrel with clopidogrel continuous therapy for 30 days (75 mg/day) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clopidogrel | Drug | repeated loading dose of clopidogrel (600 mg) in addition to high dose of clopidogrel continuous therapy for 30 days (150 mg/day) |
|
| Measure | Description | Time Frame |
|---|---|---|
| inhibition of platelet aggregation | inhibition of platelet aggregation at the 30-day follow-up visit. | at 30 days follow-up |
| inhibition of platelet aggregation | inhibition of platelet aggregation at 1st hour after administration of the repeated loading dose of clopidogrel / placebo | at 1st hour after administration of the repeated loading dose of clopidogrel / placebo |
| inhibition of platelet aggregation | inhibition of platelet aggregation at 2nd hour after administration of the repeated loading dose of clopidogrel / placebo | at 2nd hour after administration of the repeated loading dose of clopidogrel / placebo |
| inhibition of platelet aggregation | inhibition of platelet aggregation at 6th hour after administration of the repeated loading dose of clopidogrel / placebo | at 6th hour after administration of the repeated loading dose of clopidogrel / placebo |
| inhibition of platelet aggregation | inhibition of platelet aggregation at 24th hour after administration of the repeated loading dose of clopidogrel / placebo | at 24th hour after administration of the repeated loading dose of clopidogrel / placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary outcome | frequency of bleeding complications within 30 days | 30 days |
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Inclusion Criteria:
•≥18 years of age,
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roman Wojdyła, MD | Krakowskie Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii Carint Scanmed Sp. z o.o | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Krakowskie Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii Carint Scanmed Sp. z o.o | Krakow | Poland |
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| Clopidogrel | Drug | no repeated loading dose of clopidogrel with clopidogrel continuous therapy for 30 days (75 mg/day) |
|
| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| D000072658 | Non-ST Elevated 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 |
|---|---|
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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