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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
| Roche Pharma AG | INDUSTRY |
| KBM pharm | UNKNOWN |
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The purpose of this study is to compare Low-Dose, Standard-Dose Ticagrelor and Clopidogrel for Inhibition of Platelet Reactivity in Patients with Acute Coronary Syndromes
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose ticagrelor | Experimental | 60mg bid |
|
| standard dose ticagrelor | Active Comparator | 90mg bid |
|
| standard dose clopidogrel | Active Comparator | 75mg qd |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ticagrelor | Drug |
| ||
| clopidogrel |
| Measure | Description | Time Frame |
|---|---|---|
| P2Y12 reaction units(PRU) | P2Y12 Reaction Units (PRU) measured by VerifyNow P2Y12 assay | 8 hours and 30days after first randomized dose |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage inhibition of platelet aggregation | 0, 0.5, 1, 2, 4, 8,24 hours and 30 days after first randomized study treatment | |
| Aggregation units(AU), Area Under the Curve(AUC) | by Multiplate analyzer |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | Songpa-gu | 138-736 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29622168 | Derived | Park DW, Lee PH, Jang S, Lim HS, Kang DY, Lee CH, Ahn JM, Yun SC, Park SW, Park SJ. Effect of Low-Dose Versus Standard-Dose Ticagrelor and Clopidogrel on Platelet Inhibition in Acute Coronary Syndromes. J Am Coll Cardiol. 2018 Apr 10;71(14):1594-1595. doi: 10.1016/j.jacc.2018.02.010. No abstract available. |
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| Drug |
|
| 0, 0.5, 1, 2, 4, 8,24 hours and 30 days after first randomized study treatment |
| Percentage of low-responsive patients | Low-responsive patients is defined as PRU ≥ 235 from VerifyNow P2Y12 and/or percentage of platelet inhibition <15% | 0, 0.5, 1, 2, 4, 8,24 hours and 30 days after first randomized study treatment |
| Description of the pharmacokinetic (PK) profile for Ticagrelor and its metabolite AR-C124910XX | in terms of maximum concentration (Cmax),time to maximum concentration (tmax) and area under the concentration curve from time zero to infinity (AUC), t1/2, CL/F | 0, 0.5, 1, 2, 4, 8, 10,24 hours after first randomized study treatment |
| MACE(Major adverse cardiac event) | Death, Myocardial Infarction, stent thrombosis, stroke, | 30 days after first randomized study treatment |
| Adverse event | including bleeding by TIMI/PLATO criteria, dyspnea, bradycardia, syncope, | 30 days after first randomized study treatment |
| Drug tolerance | Drug tolerance is evaluated as adverse event following discontinuation of drug administration | 30 days after first randomized study treatment |
| 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 |
|---|---|
| D000077486 | Ticagrelor |
| D000077144 | Clopidogrel |
| 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 |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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