A Dose-range Finding Study of MAA868 in Patients With Atrial Fibrillation
NCT ID: NCT04213807
Last Updated: 2022-01-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
28 participants
INTERVENTIONAL
2019-12-11
2021-03-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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MAA868
Subcutaneous injection on Day 1 with two subsequent monthly injections
MAA868 Cohort 1
Subcutaneous injection: low dose
MAA868 Cohort 2
Subcutaneous injection: high dose
MAA868 Cohort 3
Subcutaneous injection: Dose to be determined.
Placebo
Subcutaneous injection: Placebo on Day 1 with two subsequent monthly injections
Placebo
Subcutaneous injection: Placebo
Interventions
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MAA868 Cohort 1
Subcutaneous injection: low dose
MAA868 Cohort 2
Subcutaneous injection: high dose
MAA868 Cohort 3
Subcutaneous injection: Dose to be determined.
Placebo
Subcutaneous injection: Placebo
Eligibility Criteria
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Inclusion Criteria
* Patients with a history of PAF or atrial flutter, as documented by (telemetry, 12 lead electrocardiography or ambulatory \[e.g. Holter\] monitor) and not due to a reversible condition (e.g. alcohol binge drinking) can be entered even if they do not have PAF at Screening. There is not time-limit for this.
* Patients with a Congestive heart failure, Hypertension, Age ( \> 65 = 1 point, \> 75 = 2 points), Diabetes, previous Stroke/transient ischemic attack (2 points) (CHA2DS2-VASc) risk score (tool as a predictor for estimating the risk of stroke in patients with atrial fibrillation (AF); Lip et al 2010) of 0-1 for men and 1-2 for women and in whom, in the investigator's judgment, the use of an anticoagulant for stroke prevention is not indicated
Exclusion Criteria
* History of major bleeding during treatment with an anticoagulant or antiplatelet therapy. (Patients who have had major bleeding on anticoagulants or antiplatelet therapy more than a year ago can be enrolled only if the bleeding was due to a reversible cause, e.g. gastro-duodenal ulcer that was successfully treated.)
* History of traumatic or non-traumatic intracranial, intraspinal or intraocular bleeding
* Known bleeding diathesis or any known active bleeding site at screening or baseline
* Family history of bleeding disorder
* Known active GI lesions predisposing to bleeding events
* Myocardial infarction, unstable angina pectoris or coronary artery bypass graft (CABG) surgery within 12 months prior to the Screening period
* Known clinically significant valvular heart disease including moderate or severe mitral stenosis (valve area \<1.5 cm2)
* Patients with a prosthetic heart valve
18 Years
85 Years
ALL
No
Sponsors
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Covance
INDUSTRY
Anthos Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Norman E Lepor, MD FACC FAHA FSCAI
Role: PRINCIPAL_INVESTIGATOR
Westside Medical Associates of Los Angeles
Locations
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Anthos Investigative Site
Beverly Hills, California, United States
Anthos Investigative Site
Wichita, Kansas, United States
Anthos Investigative Site
Alexandria, Louisiana, United States
Anthos Investigative Site
Lansing, Michigan, United States
Anthos Investigative Site
Wynnewood, Pennsylvania, United States
Anthos Investigative Site
McKinney, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ANT-004
Identifier Type: -
Identifier Source: org_study_id
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