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A 4 week-duration cross-over study on Ticagrelor and Clopidogrel for the Acute Coronary Syndrome (ACS) and Chronic Kidney Disease (CKD) subjects, focusing on the platelet inhibition and safety observation.
Acute coronary syndrome is a high mortality and costly disease. Antiplatelet therapies, including aspirin and P2Y12 antagonist, play important roles at the acute and subacute stage treatment for acute coronary syndrome, especially after coronary stent implantation. Patients with decreased estimated glomerular filtration rate (eGFR) experience higher cardiovascular morbidity and mortality. Clopidogrel, one of P2Y12 receptor antagonists, inhibits the receptor's activation by blocking its interaction with ADP. However, the efficacy of clopidogrel shows substantial variation and residual platelet reactivity, which is related to adverse cardiovascular outcome, especially in impaired renal function. Our study aims to check the platelet inhibition rate comparing both medication with a cross-over study among CKD subjects and ACS condition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clopidogrel first | Experimental | Clopidogrel (Plavix) 75 mg qd, 2 weeks; followed with Ticagrelor (Brilinta) 90 mg bd, 2 weeks |
|
| Ticagrelor first | Experimental | Ticagrelor (Brilinta) 90 mg bd, 2 weeks; followed with Clopidogrel (Plavix) 75 mg qd, 2 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clopidogrel first | Drug | After randomization, 2 weeks Clopidogrel (Plavix) 75 mg QD will be given and then crossover with following 2 weeks Ticagrelor (Brilinta) 90 mg bd |
|
| Measure | Description | Time Frame |
|---|---|---|
| platelet VerifyNow inhibition rate and Platelet Residual Unit (PRU) values changes | baseline, 2 weeks and 4 weeks later (compare cross over effect) |
| Measure | Description | Time Frame |
|---|---|---|
| Major bleeding events | assessed by TIMI bleeding score: mild, moderate and severe; the transfusion of packed red blood cell amount; decreased count in Hb (>2.5) | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Myocardial infarction | 1 year | |
| emergent condition with hospitalization need | Number of subjects with an emergent condition that required hospitalization | 30 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ping-Yen Liu, MD, PhD. | Contact | +88662353535 | 4602 | larry@mail.ncku.edu.tw |
| Name | Affiliation | Role |
|---|---|---|
| Ping-Yen Liu, MD, PhD. | National Cheng Kung University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Internal Medicine, National Cheng Kung University Hospital | Recruiting | Tainan | 704 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35224730 | Derived | Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4. |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D051436 | Renal Insufficiency, Chronic |
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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|
| Ticagrelor first | Drug | After randomization, 2 weeks Ticagrelor (Brilinta) 90 mg bd will be given then crossover with following 2 weeks Clopidogrel (Plavix) 75 mg QD |
|
|
| D051437 |
| Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |