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Lp(a) levels play an important role in predicting subsequent ischemic events in patients with established coronary artery disease (CAD), especially those who underwent PCI. However, there are still no approved pharmacologic therapies that specifically target high Lp(a) levels.
DAPT consisting of aspirin and a P2Y12 receptor inhibitor represents the cornerstone of pharmacological treatment aimed at preventing thrombotic complications after PCI. Considering that Lp(a) has a prothrombotic effect through its inactive, plasminogen-like protease domain on apo(a), the investigators speculate that prolonged DAPT may have a beneficial effect on reducing future ischemic events in patients with elevated Lp(a) levels after PCI. Some observational studies revealed that DAPT > 1 year was significantly associated with lower risk of cardiovascular events compared with DAPT ≤ 1 year in patients with elevated Lp(a) levels who were event-free at 1 year after PCI with DES. However, the relative efficacy and safety of prolonged DAPT versus standard DAPT in this high-risk population has never been assessed in randomized controlled trials (RCTs).
The DAPT-Lp(a) trial is a multicenter, parallel-group, randomized controlled trial with blinded end-point evaluation. Consecutive patients with Lp(a) levels>30mg/dL who meet the inclusion criteria and none of the exclusion criteria will be randomized in a 1:1 fashion to 24-month DAPT group or 12-month DAPT group. The investigators hypothesise that, in patients with Lp(a) levels >30mg/dL who were event-free at 1 year after PCI with DES, 24-month DAPT is superior to 12-month DAPT with respect to major adverse cardiovascular and cerebrovascular events (primary end point), while it is non-inferior to 12-month DAPT with respect to net adverse clinical events (key secondary end point).
The investigators estimated that 3,300 patients would be needed to provide the necessary number of confirmed endpoints to test the study hypothesis. Patients will be followed up at 3, 6, 9, 12 months after randomization. All analyses will be performed according to the intention-to-treat (ITT) principle.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 24 Months DAPT | Experimental | Dual antiplatelet therapy consisting of aspirin and clopidogrel will be continued for 12 months after randomisation. |
|
| 12 Months DAPT | Active Comparator | Aspirin + a placebo that is exactly the same in size, color, smell, taste and appearance as clopidogrel were administered for 12 months after randomisation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 24 Months DAPT | Procedure | All subjects will receive co-administration of aspirin (100 mg/day) and clopidogrel (75 mg/day) for 12 months after randomization. The DAPT will last for 24 months after PCI. |
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiovascular and cerebrovascular event (MACCE) | The primary endpoint was major adverse cardiovascular and cerebrovascular event (MACCE), defined as a composite of all-cause death, non-fatal myocardial infarction or stroke. | 12 months after randomization |
| BARC type 3 or 5 bleeding | Number of patients with a first occurrence of adjudicated BARC type 3 or 5 bleeding | 12 months after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Net adverse clinical event (NACE) | The key secondary endpoint was net adverse clinical event, defined as a composite of all-cause death, non-fatal myocardial infarction, stroke or Bleeding Academic Research Consortium (BARC)] type 3 or 5 bleeding. | 12 months after randomization |
| Cardiovascular death or myocardial infarction |
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Inclusion Criteria:
Exclusion Criteria:
22. Refusal to participate in the study
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kefei Dou, MD, PhD | Contact | +86-10-13801032912 | drdoukefei@126.com | |
| Kongyong Cui,, PhD | Contact | +86-10-15210519790 | cardio_kongyong@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Kefei Dou, MD, PhD | Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College | Principal Investigator |
| Kongyong Cui, MD, PhD | Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College | Recruiting | Beijing | Beijing Municipality | 100037 | China |
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Study investigators, clinicians, participants, clinical assessors (including the follow-up research personnel, clinical events committee [CEC]) were unaware of the study-group assignments. All potential events were adjudicated according to prespecified criteria by an independent clinical events committee whose members were unaware of the trial-group assignments.
| 12 Months DAPT | Procedure | All the subjects will receive aspirin (100 mg/day) + a placebo that is exactly the same in size, color, smell, taste and appearance as clopidogrel for 12 months after randomization. The DAPT will last for 12 months after PCI. |
|
Number of patients with a first occurrence of adjudicated composite of cardiovascular death or myocardial infarction. |
| 12 months after randomization |
| All-cause death or myocardial infarction | Number of patients with a first occurrence of adjudicated composite of all-cause death or myocardial infarction. | 12 months after randomization |
| Stent thrombosis | Number of patients with the adjudicated stent thrombosis. | 12 months after randomization |
| Any myocardial infarction | Number of patients with a first occurrence of adjudicated any myocardial infarction. | 12 months after randomization |
| Target vessel myocardial infarction | Number of patients with a first occurrence of adjudicated target vessel myocardial infarction. | 12 months after randomization |
| Stroke | Number of patients with a first occurrence of adjudicated stroke. | 12 months after randomization |
| Ischemic stroke | Number of patients with a first occurrence of adjudicated ischemic stroke. | 12 months after randomization |
| Hemorrhagic stroke | Number of patients with a first occurrence of adjudicated hemorrhagic stroke. | 12 months after randomization |
| Cardiovascular death | Number of patients with the occurrence of adjudicated cardiovascular death. | 12 months after randomization |
| All-cause death | Number of patients with a first occurrence of adjudicated confirmed all-cause death | 12 months after randomization |
| Repeat revascularization | Number of patients with a first occurrence of adjudicated repeat revascularization. | 12 months after randomization |
| Target vessel revascularization | Number of patients with a first occurrence of adjudicated target vessel revascularization. | 12 months after randomization |
| BARC type 2, 3 or 5 bleeding | Number of patients with a first occurrence of adjudicated BARC type 2, 3 or 5 bleeding. | 12 months after randomization |
| Any bleeding | Number of patients with a first occurrence of adjudicated any bleeding. | 12 months after randomization |
|
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C028145 | 2'-deoxythymidylyl-(3'-5')-2'-deoxyadenosine |
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