The Aortic Valve DECalcification (AVADEC) Trial
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 400
Summary
- Conditions
- Aortic Valve Stenosis
- Multidetector Computed Tomography
- Randomised Clinical Trial
- Vitamin K 2
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Subjects will be randomized 1:1 after strati?cation for site, AVC score (300-599 or ?600) and statin-use. Each site will be provided with sequentially numbered, opaque and sealed envelopes containing randomly generated treatment allocations. Four different types of envelopes are provided; 1) AVC 300-599, no statin-use; 2) AVC 300-599, statin-use; 3) AVC ?600, no statin-use; and 4) AVC ?600, statin-use.Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: The randomization-list is available to the data and safety monitoring board, but patients, nurses, physicians and other data collectors are kept blinded to the allocation during the study.Primary Purpose: Prevention
Participation Requirements
- Age
- Between 65 years and 75 years
- Gender
- Only males
Description
Not Provided
Not Provided
Tracking Information
- NCT #
- NCT03243890
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Axel CP Diederichsen, PhD Odense University Hospital
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