Phase 4 Heart Disease Trial, Recruiting NCT05152888 Sponsor: Brigham and Women's Hospital Condition: Heart Disease
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Phase 4 Heart Disease Trial, Recruiting

NCT05152888
Recruiting Phase 4

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Men aged 50 or older, or women aged 55 or older
  • People with an LDL ("bad") cholesterol level of 70 mg/dL or higher
  • People with stable coronary artery disease (meaning no surgery to open blocked arteries is planned before the study begins), confirmed by one or more of the following:
    • A nuclear heart scan showing a significant area of the heart not getting enough blood flow, or low blood flow measurements during the scan
    • A coronary artery imaging test (either invasive or CT-based) showing blockages of 50% or more in at least two heart arteries, or widespread artery disease across three vessels
    • A coronary calcium score above 100 combined with at least one additional heart disease risk factor, or a calcium score above 300
  • People already taking a cholesterol-lowering statin medication must have been on a stable dose for at least 3 months before enrolling

Who may not be able to join:

  • People with a history of heart attack or stroke
  • People who had coronary bypass surgery (CABG) less than 3 months before screening
  • People with a genetic condition called homozygous familial hypercholesterolemia (a severe inherited cholesterol disorder)
  • People who have had a heart transplant
  • People whose heart pumping function is significantly reduced (below 40%), or who have severe heart failure or severe chest pain symptoms
  • People with certain structural heart muscle conditions (infiltrative or hypertrophic cardiomyopathy)
  • People with severe heart valve disease
  • People with uncontrolled or recurring dangerous heart rhythm problems (ventricular tachycardia)
  • People with fasting triglyceride (blood fat) levels above 500 mg/dL
  • People with significantly reduced kidney function (GFR below 30 mL/min/1.73m²)
  • People currently using a PCSK-9 inhibitor medication
  • People who are currently pregnant or breastfeeding
  • People who cannot receive vasodilator medications (drugs that widen blood vessels) for any reason
  • People with a latex allergy (note: those with a latex allergy may still be eligible for a parallel control group — confirm with the trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Diana Lopez, MD, Brigham and Women's Hospital

Phone: 617-525-8268

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 4
Registry
ClinicalTrials.gov
Start date
3 March 2022
Est. completion
31 March 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Coronary Flow Reserve; Stress Myocardial Blood Flow (MBF)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov