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The present study is aimed to compare the safety and efficacy of Ticagrelor with low-dose Aspirin versus standard dual anti-platelet therapy (DAPT) in patients with acute coronary syndrome (ACS) at high risk for ischemic events after percutaneous coronary intervention (PCI) and stent implantation.
This is a prospective, randomized, open-label, blinded-endpoint evaluation, single-center Study. There will be 1220 ACS patients at high risk for ischemic events after successful PCI with implantation of at least one drug eluting stent who will be enrolled in Fuwai Hospital, China. Then those included subjects will be randomized to either Ticagrelor plus low-dose Aspirin (50mg daily, LD group) or Ticagrelor plus regular dose Aspirin (75mg daily, control group) for 12 months. The primary endpoint of the current study is to determine the impact of low-dose Aspirin plus Ticagrelor versus standard DAPT for 12 months on major adverse cardiac and cerebral events (MACCEs), and the secondary endpoint is to determine whether the protocol of low dose Aspirin plus Ticagrelor reduces bleeding events, sufficiently inhibits platelet function, and increases the medication adherence among the included patients. In summary, the present study is to provide new evidence and strategy about the anti-platelet protocol for ACS patients at high risk for ischemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LD group | Experimental | Low-dose Aspirin(50mg qd) + Ticagrelor( 90mg bid) for 12 months |
|
| Control group | Active Comparator | Regular Aspirin(75mg qd) + Ticagrelor(90mg bid) for 12 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin | Drug | Comparison of 12 months of ticagrelor and low-dose aspirin versus 12 months of standard dual anti-platelet therapy (DAPT) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiac and cerebral events (MACCEs) | Number of participants with a composite of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke or urgent target vessel revascularization | 12 months after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding episode (Key secondary endpoint) | Number of participants with major bleeding(Bleeding Academic Research Consortium (BARC) types ≥3) and/or minor bleeding(Bleeding Academic Research Consortium (BARC) types 0-2) | 12 months after randomization |
| Platelet function |
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Inclusion Criteria:
Clinical inclusion criteria:
Angiographic Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haiyan Qian, MD, PhD | Contact | +8613811386143 | ahqhy712@163.com | |
| Zhiyao Wei | Contact | +8615521192379 | weizhiyaoyx@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Haiyan Qian, MD, PhD | Fuwai Hospital, Beijing, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Hospital | Recruiting | Beijing | Beijing Municipality | China |
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|
| Ticagrelor | Drug | Comparison of 12 months of ticagrelor and low-dose aspirin versus 12 months of standard dual anti-platelet therapy (DAPT) |
|
|
Platelet inhibition, blood level and urine level of thromboxaneB2(TXB2) |
| 12 months after randomization |
| Medication adherence | 12 months after randomization |
| Bleeding-related withdrawal | 12 months after randomization |
| 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 |
|---|---|
| D001241 | Aspirin |
| D000077486 | Ticagrelor |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| 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 |
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