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NCT05152888 · ClinicalTrials.gov registry record · Phase 4
The Impact of Pcsk-9 Inhibition on PET CFR in Patients at High CV Risk
A Phase 4 study of Stable Coronary Disease, sponsored by Brigham and Women's Hospital.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT05152888: Recruiting Phase 4 study of Stable Coronary Disease, sponsored by Brigham and Women's Hospital.
NCT05152888 is a Phase 4 study of Stable Coronary Disease that is actively recruiting participants, run by Brigham and Women's Hospital. The registered enrollment target is 50 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05152888, a Phase 4 study of Stable Coronary Disease, is actively recruiting participants, sponsored by Brigham and Women's Hospital.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
The study protocol is a single-arm, open label pilot study designed to evaluate the impact of PCSK-9 inhibition on coronary blood flow in patients with stable coronary artery disease. Patients with stable coronary artery disease will be recruited from the BWH Cardiovascular Medicine clinic and/or from the BWH Nuclear Cardiology Laboratory. A target sample size of 50 participants will undergo imaging with N-13 ammonia or Rubidium-82 positron emission tomography (PET) and coronary computed tomography angiography (CCTA) before and after 12 months of PCSK-9 inhibition with Evolocumab to assess changes in myocardial blood flow, and plaque volume. To help account for physiological changes that may occur in myocardial blood flow and inflammatory biomarkers during the study period, we will also recruit a parallel control group of stable CAD patients who will undergo similar baseline and 12-month imaging and biomarker assessment. We plan to recruit 15 patients in the parallel control group.
Primary Outcome
Change in global coronary flow reserve (CFR) after 12 months of therapy with Evolocumab
Conditions Studied
Interventions
- DRUG Evolocumab
Study Locations (1)
Massachusetts
- Brigham and Women's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2022-03-03 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 4 |
What NCT05152888 shows while recruiting
NCT05152888 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Stable Coronary Disease appearing as the primary indexed condition, and to 1 intervention - of which Evolocumab is the first listed.
NCT05152888 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05152888 about?
NCT05152888 is a clinical study titled "The Impact of Pcsk-9 Inhibition on PET CFR in Patients at High CV Risk". The study protocol is a single-arm, open label pilot study designed to evaluate the impact of PCSK-9 inhibition on coronary blood flow in patients with stable coronary artery disease. Patients with stable coronary artery disease will be recruited from the BWH Cardiovascular Medicine clinic and/or fr...
What is the current status of trial NCT05152888?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 50 participants. The study started on 2022-03-03. Estimated completion is 2027-12-31.
What conditions does trial NCT05152888 study?
This clinical trial studies the following conditions: Stable Coronary Disease.
What interventions are being tested in trial NCT05152888?
The interventions under investigation include: Evolocumab (DRUG).
Who is sponsoring clinical trial NCT05152888?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05152888 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05152888's enrollment target sits among peer trials
50 1255th of 2000 higher than 679 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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