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The primary objective of this study is to compare platelet reactivity between patients receiving a loading dose of clopidogrel and a reloading dose of prasugrel to patients receiving only a loading dose of prasugrel.
This is a prospective, open-label, non-randomized trial of approximately 260 patients with Acute Coronary Syndrome (ACS) undergoing percutaneous coronary intervention (PCI). In order to compare platelet reactivity, as assessed by the VerifyNow P2Y12 assay, we plan to recruit two study groups of interest:
A subset of 40 patients from each study group (80 patients total) will undergo additional platelet reactivity testing with the vasodilator stimulated phosphoprotein (VASP) assay.All patients will be followed throughout the duration of the hospital stay.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients who have received loading dose of clopidogrel | Experimental |
| |
| Patients who have not received loading dose of clopidogrel | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prasugrel | Drug | Patients who have received 600 mg loading dose of clopidogrel will receive a reloading dose of 60 mg prasugrel |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary objective is to compare platelet reactivity, as assessed by the VerifyNow P2Y12 assay, between patients receiving a loading dose of clopidogrel and a reloading dose of prasugrel to patients receiving only a loading dose of prasugrel. | Average hospital stay is 24-48 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| The secondary objective of this study is to describe rates of bleeding events associated with a loading dose of prasugrel in patients who have already received a loading dose of clopidogrel. | Average hospital stay is 24-48 hours. |
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Inclusion Criteria:
Patients age 18 or older, of both genders
Presenting with an ACS, defined as at least two of the following:
Symptoms consistent with myocardial ischemia; ST segment elevation or depression of at least 1 mm in 2 or more contiguous leads on EKG; Cardiac troponin I level above the upper limit of normal.
An initial invasive strategy (e.g. early angiography) is planned.
No contraindications to prasugrel therapy.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ron Waksman, MD | Medstar Health Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Heart Center | Huntsville | Alabama | 35801 | United States | ||
| Washington Hospital Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25041356 | Result | Lhermusier T, Lipinski MJ, Drenning D, Marso S, Chen F, Torguson R, Waksman R. Switching patients from clopidogrel to prasugrel in acute coronary syndrome: impact of the clopidogrel loading dose on platelet reactivity. J Interv Cardiol. 2014 Aug;27(4):365-72. doi: 10.1111/joic.12139. Epub 2014 Jul 19. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 3, 2022 | |
| Reset | Feb 1, 2022 | |
| Release | May 24, 2022 | |
| Reset | Jun 16, 2022 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 3, 2022 | Feb 1, 2022 | |||
| May 24, 2022 |
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000068799 | Prasugrel Hydrochloride |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D010879 | Piperazines |
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| Prasugrel | Drug | Patients who have not received a loading dose of clopidogrel will receive a 60 mg loading dose of prasugrel. |
|
| Washington D.C. |
| District of Columbia |
| 20010 |
| United States |
| Sinai Center for Thrombosis Research | Baltimore | Maryland | 21215 | United States |
| Saint Luke's Hospital | Kansas City | Missouri | 64111 | United States |
| Jun 16, 2022 |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |