AtRial Cardiopathy and Antithrombotic Drugs In Prevention After Cryptogenic Stroke


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This study is not yet open for participant recruitment.

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Verified June 2017 by Mitchell S Elkind, Columbia University

Sponsor:

Collaborators:

National Institute of Neurological Disorders and Stroke (NINDS)

University of Cincinnati

Medical University of South Carolina

Bristol-Myers Squibb

Pfizer

Roche Pharma AG

Information provided by (Responsible Party):

Mitchell S Elkind, Columbia University

ClinicalTrials.gov Identifier:

NCT03192215

First received: June 16, 2017

Last updated: June 16, 2017

Last verified: June 2017

Objectives

  • Primary: To test the hypothesis that apixaban is superior to aspirin for the prevention of recurrent stroke in patients with cryptogenic ischemic stroke and atrial cardiopathy.
  • Secondary: To test the hypothesis that the relative efficacy of apixaban over aspirin increases with the severity of atrial cardiopathy.

Stroke Drug: Apixaban Drug: Aspirin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Active treatment will be either apixaban 5 mg or aspirin 81 mg. An adjusted dose of apixaban 2.5 mg will be used for subjects with at least two of the following: age greater than or equal to 80 years, body weight less than or equal to 60 kg, or known serum creatinine greater than or equal to 1.5 mg/dL. There will be six possible study tablets: apixaban 5 mg (regular dose), apixaban 2.5 mg (adjusted dose), apixaban 5 mg placebo, apixaban 2.5 mg placebo, aspirin 81 mg, and aspirin placebo.

All subjects will be randomized to receive active treatment with either active apixaban or active aspirin. Study treatments will be supplied in a double-dummy fashion as apixaban 5 mg (2.5 mg for the adjusted dose) or matching placebo, and aspirin 81 mg or matching placebo.

Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Masking Description:

Eligible patients will be allocated in a 1:1 ratio to apixaban or aspirin using the minimal sufficient balance randomization method to prevent serious treatment imbalances by study site.

Primary Purpose: Prevention

Official Title: AtRial Cardiopathy and Antithrombotic Drugs In Prevention After Cryptogenic Stroke

Primary Outcome Measures:

Secondary Outcome Measures:

Estimated Enrollment: 1100
Anticipated Study Start Date: September 1, 2017
Estimated Study Completion Date: April 30, 2022
Estimated Primary Completion Date: October 31, 2021 (Final data collection date for primary outcome measure)
Experimental: Active agent: Apixaban

Patients with a recent embolic stroke of undetermined source (ESUS) and evidence of atrial cardiopathy will receive Apixaban

Drug: Apixaban

5 mg by mouth twice daily (2.5 mg for subjects meeting standard criteria for an adjusted dose).

Other Name: Eliquis

Active Comparator: Active control: Aspirin

Patients with a recent embolic stroke of undetermined source (ESUS) and evidence of atrial cardiopathy will receive Aspirin

Drug: Aspirin

Aspirin 81 mg by mouth once daily.

Other Name: Aspirin Tablet

ARCADIA is a multicenter, biomarker-driven, randomized, double-blind, active-control, phase 3 clinical trial of apixaban versus aspirin in patients who have evidence of atrial cardiopathy and a recent stroke of unknown cause. Eleven hundred subjects will be recruited over 2.5 years at 120 sites in the NINDS StrokeNet consortium. Subjects will be followed for a minimum of 1.5 years and a maximum of 4 years for the primary efficacy outcome of recurrent stroke and the primary safety outcomes of symptomatic intracranial hemorrhage and major hemorrhage other than intracranial hemorrhage.

Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Exclusion Criteria:

  • History of AF, AF on 12-lead ECG, or any AF of any duration during heart-rhythm monitoring prior to randomization.
  • Clear indication for treatment-dose anticoagulant therapy, such as venous thromboembolism or a mechanical heart valve.
  • Need for antiplatelet agent other than aspirin, such as clopidogrel after implantation of a coronary artery stent. Open-label therapy with aspirin up to 244 mg/day is allowed.
  • History of spontaneous intracranial hemorrhage.
  • Chronic kidney disease with serum creatinine ≥2.5 mg/dL.
  • Active hepatitis or hepatic insufficiency with Child-Pugh score B or C.
  • Clinically significant bleeding diathesis.
  • Unresolved anemia (hemoglobin <9 g/dL) or thrombocytopenia (<100 x 10E9/L).
  • Clinically significant gastrointestinal bleeding within the past year (e.g., not due to external hemorrhoids).
  • At risk for pregnancy: premenopausal or postmenopausal woman within 12 months of last menses without a negative pregnancy test or not committing to adequate birth control, which includes an oral contraceptive, two methods of barrier birth control such as condom with or without spermicidal lubricant + diaphragm, or abstinence.
  • Known allergy or intolerance to aspirin or apixaban.
  • Concomitant participation in another clinical trial involving a drug or acute stroke intervention.
  • Considered by the investigator to have a condition that precludes follow-up or safe participation in the trial.
  • Inability of either participant or surrogate to provide written, informed consent for trial participation.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03192215

Columbia University

National Institute of Neurological Disorders and Stroke (NINDS)

University of Cincinnati

Medical University of South Carolina

Bristol-Myers Squibb

Pfizer

Roche Pharma AG

Principal Investigator: Mitchell SV Elkind, MD Columbia University

Additional Information:

Publications:

Responsible Party: Mitchell S Elkind, Professor of Neurology and Epidemiology in the Gertrude H. Serg, Department of Neurology Stroke, Columbia University
ClinicalTrials.gov Identifier: NCT03192215     History of Changes
Other Study ID Numbers: AAAR4607
1U01NS095869-01A1 ( US NIH Grant/Contract Award Number )
Study First Received: June 16, 2017
Last Updated: June 16, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Mitchell S Elkind, Columbia University:

Atrial Cardiopathy
Cryptogenic stroke
Ischemic stroke
Apixaban
Aspirin

Additional relevant MeSH terms:

Stroke
Heart Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Aspirin
Apixaban
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Anticoagulants

ClinicalTrials.gov processed this record on June 20, 2017