Apixaban Versus Dual-antiplatelet Therapy (Clopidogrel and Aspirin) in Acute Non-disabling Cerebrovascular Events "ADANCE"

Not yet recruiting

Phase 2/3 Results N/A

Trial Description

Nondisabling cerebrovascular events represent the largest group of cerebrovascular disease with a high risk of recurrent stroke. A recent trial indicated that clopidogrel and aspirin treatment reduced the risk of recurrent stroke and was not associated with increased hemorrhage events, compared with aspirin monotherapy. Apixaban, a new oral anticoagulant, is proved to be as effective as traditional anticoagulants with less risk of bleeding events.
To estimate whether apixaban is beneficial for acute TIA or minor stroke, a randomized, double-blind, multicenter, controlled clinical trial has been designed. The investigators will assess the hypothesis that a 21-days apixaban regimen is superior to clopidogrel and aspirin dual-therapy for the treatment of high-risk patients with acute nondisabling cerebrovascular event.

Detailed Description

The ADANCE study is a randomized, double-blind clinical trial with a target enrollment of 3,000 Chinese patients. Two subtypes of patients will be enrolled: I, acute disabling ischemic stroke (<24 hours of symptoms onset); II, acute TIA (<24 hours of symptoms onset).
Patients will be randomized into 3 groups:
Ⅰ Receiving a 75 mg dose of clopidogrel and 75mg dose of aspirin from day 1 to day 21, with placebo apixaban twice daily.
Ⅱ Receiving a 2.5-mg twice daily of apixaban, with placebo clopidogrel and placebo aspirin from day 1 to day 21.
Ⅲ Receiving a 5-mg twice daily of apixaban, with placebo clopidogrel and placebo aspirin from day 1 to day 21.
From day 22 to 3 months, all patients will receive 75-mg dose of clopidogrel long-term antiplatelet therapy.
The primary efficacy end point is percentage of patients with new stroke (ischemic or hemorrhage) at 90 days.

Conditions

Interventions

  • Clopidogrel (Plavix®)Drug
    Other Names: Plavix
    Intervention Desc: an irreversible inhibitor of the P2Y12 adenosine diphosphate receptor
    ARM 1: Kind: Experimental
    Label: Dual-antiplatelet Therapy
    Description: Receiving a 75 mg dose of clopidogrel and 75mg dose of aspirin from day 1 to day 21, with placebo apixaban twice daily
  • Aspirin Drug
    Other Names: Aspirin at bedtime
    Intervention Desc: a non-steroidal anti-inflammatory drug
    ARM 1: Kind: Experimental
    Label: Dual-antiplatelet Therapy
    Description: Receiving a 75 mg dose of clopidogrel and 75mg dose of aspirin from day 1 to day 21, with placebo apixaban twice daily
  • Placebo Drug
    ARM 1: Kind: Experimental
    Label: Dual-antiplatelet Therapy
    Description: Receiving a 75 mg dose of clopidogrel and 75mg dose of aspirin from day 1 to day 21, with placebo apixaban twice daily
    ARM 2: Kind: Experimental
    Label: Apixaban 2.5mg
    Description: Receiving a 2.5-mg twice daily of apixaban, with placebo clopidogrel and placebo aspirin from day 1 to day 21
    ARM 3: Kind: Experimental
    Label: Apixaban 5mg
    Description: Receiving a 5-mg twice daily of apixaban, with placebo clopidogrel and placebo aspirin from day 1 to day 21
  • Apixaban Drug
    Other Names: BMS-562247
    Intervention Desc: orally active direct factor Xa inhibitor
    ARM 1: Kind: Experimental
    Label: Apixaban 2.5mg
    Description: Receiving a 2.5-mg twice daily of apixaban, with placebo clopidogrel and placebo aspirin from day 1 to day 21
    ARM 2: Kind: Experimental
    Label: Apixaban 5mg
    Description: Receiving a 5-mg twice daily of apixaban, with placebo clopidogrel and placebo aspirin from day 1 to day 21

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary percentage of patients with new stroke (ischemic or hemorrhage) 90 days No
Secondary Percentage of patients with new clinical vascular events (ischemic stroke/hemorrhagic stroke/TIA/myocardial infarction/vascular death) 30 days Yes
Secondary Changes in NIHSS scores 90 days No
Secondary moderate to severe bleeding events 90 days No
Secondary Total mortality 90 days Yes
Secondary Adverse events/severe adverse events reported by the investigators 90 days Yes

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