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| ID | Type | Description | Link |
|---|---|---|---|
| ISSBRIL0149 | Other Identifier | AstaZeneca |
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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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The primary objective is to determine the pharmacodynamic effect of ticagrelor dosing (180mg LD/ 90mg BID) at 2, 4 hours and 14 days in stable Coronary artery disease (CAD) patients who exhibit high-on prasugrel platelet reactivity defined as Vasodilator Stimulated Phosphoprotein-Phosphorylation (VASP-P) >50%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-HPR group | No Intervention | The non-HPR group will have PD and genetic testing, with no change in medication. | |
| HPR Group | Active Comparator | This arm will be split into Group A and Group B which will receive Ticagrelor/Prasugrel in a crossover manner. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prasugrel | Drug | Patients will discontinue ticagrelor treatment and start 10 mg prasugrel daily while continuing 81 mg of aspirin daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamic (PD) Vasodilator Stimulated Phosphoprotein-Phosphorylation(VASP-P) in High On Prasugrel Platelet Reactivity(HPPR) stable CAD patients | The primary objective is to determine the pharmacodynamic effect of ticagrelor dosing (180mg LD/ 90mg BID) at 2, 4 hours and 14 days in stable CAD patients who exhibit high-on prasugrel platelet reactivity defined as VASP-P>50%. | 2 hours, 4 hours, and 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of HPPR | Determine the prevalence of HPPR in a stable PCI population. | 2 hours, 4 hours, and 14 days |
| CYP2C19 relation to occurence of HPPR | Determine the relation of CYP2C19 activity to the occurrence of HPPR. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events | To evaluate the safety and tolerability of switching subjects from Prasugrel to Ticagrelor and vice versa. | 14 days, 28 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kevin P Bliden, BS, MBA | Contact | 4106014795 | kbliden@lifebridgehealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Paul A Gurbel, MD | LifeBridge Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sinai Center for Thrombosis Research | Recruiting | Baltimore | Maryland | 21215 | United States |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000068799 | Prasugrel Hydrochloride |
| D000077486 | Ticagrelor |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D010879 | Piperazines |
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| Ticagrelor | Drug | Patients will be given 180 mg of Ticagrelor followed by 90 mg twice a day while continuing 81 mg of aspirin daily). |
|
| 2 hours, 4 hours, and 14 days |
| PD VerifyNow in HPPR stable CAD patients | Evaluate the PD effect of ticagrelor dosing (180mg LD/ 90mg BID) at 2, 4 hours and 14 days in stable CAD patients who exhibit HPPR defined as PRU >208 by VerifyNow P2Y12 | 2 hour, 4 hour, 14 days |
| PD LTA in HPPR stable CAD patients | Evaluate the PD effect of ticagrelor dosing (180mg LD/ 90mg BID) at 2, 4 hours and 14 days in stable CAD patients who exhibit HPPR based on light transmittance aggregometry (5 and 20 uM ADP, 4ug/mL Collagen) | 2 hours, 4 hours, 14 days |
| Frequency of HPR | To determine the frequency of HPR after switching from ticagrelor to prasugrel after 14 days of treatment. | 2 hours, 4 hours, and 14 days |
| PD effect(Prasugrel) relation to CYP2C19 | To determine if the PD effect of prasugrel is related to the activity of CYP2C19 (phenotyping and genotyping) by measuring patients with and without HPPR. | 2 hours, 4 hours, and 14 days |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |