Trials / Terminated
TerminatedNCT03542110
The Alirocumab for Stopping Atherosclerosis Progression in Saphenous Vein Grafts (ASAP-SVG) Pilot Trial
Effect of Alirocumab on Saphenous Vein Graft Atherosclerosis: The Alirocumab for Stopping Atherosclerosis Progression in Saphenous Vein Grafts (ASAP-SVG) Pilot Trial
- Status
- Terminated
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 46 (actual)
- Sponsor
- Minneapolis Heart Institute Foundation · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a phase IV, multi-center, double-blind, randomized, placebo- controlled study evaluating the effect of alirocumab on SVG atherosclerotic disease burden, as assessed by IVUS at baseline and following 78 weeks of treatment in subjects with at least one intermediate SVG lesion receiving optimal statin therapy. Subjects will be randomized 1:1 into 2 treatment groups: alirocumab 150 mg subcutaneously every 2 weeks or placebo subcutaneously every 2 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Alirocumab 150 MG/ML subcutaneous injection | Single-dose, pre-filled, disposable, subcutaneous injection pen |
| DRUG | Matching Placebo subcutaneous injection | Single-dose, pre-filled, disposable, subcutaneous injection pen |
Timeline
- Start date
- 2018-08-04
- Primary completion
- 2020-06-30
- Completion
- 2020-07-31
- First posted
- 2018-05-31
- Last updated
- 2021-09-16
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03542110. Inclusion in this directory is not an endorsement.