Phase 4 Heart Disease Trial, Recruiting NCT05618353 Sponsor: VA Office of Research and Development Condition: Heart Disease
Back to Heart Disease

Phase 4 Heart Disease Trial, Recruiting

NCT05618353
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:

  • People (men and women) who have previously had a procedure to open or bypass blocked heart arteries, OR who have been found on heart imaging to have significant blockages in major heart arteries.
  • People who are scheduled for a type of surgery considered to carry an intermediate or high risk to the heart — such as abdominal, brain, chest, or major vascular surgery.
  • People scheduled for only a minimally invasive or keyhole-type surgical approach may also be eligible if at least one of the following is also present: a past heart attack, a history of heart failure, a past stroke or mini-stroke, use of insulin before surgery, or a certain level of reduced kidney function before surgery (confirm with trial site).

Who may not be able to join:

  • People who have used the medication colchicine within the past month, or who have had a bad reaction to colchicine in the past.
  • People who have inflammatory bowel disease with a history of diarrhoea as a symptom, or who experience ongoing chronic diarrhoea.
  • People who have a pre-existing and progressing neuromuscular disease, such as ALS (motor neurone disease), inherited muscle disorders, muscle inflammation conditions, myasthenia gravis, or Lambert-Eaton syndrome.
  • People whose kidneys are functioning at a low level (filtration rate below 30 mL/minute) or who are on dialysis.
  • People with a history of cirrhosis, long-term active hepatitis, or serious liver disease.
  • People with a history of a blood disorder called myelodysplasia who currently show signs of low blood cell counts.
  • People who have an active infection at the time of enrolment, indicated by fever, abnormal white blood cell counts, or current antibiotic use.
  • People who are currently receiving chemotherapy or biological treatments that affect the immune system.
  • People who are pregnant, breastfeeding, or planning to become pregnant during the study period.
  • People who are already participating in another competing research study, or who are not able to give their own consent to participate.
  • People with any other significant health condition that the trial team determines could increase risk, interfere with results, or make it difficult to follow the study procedures (confirm with trial site).
  • People who are currently taking certain medications that can interact with the study drug — specifically strong inhibitors of CYP3A4 or P-glycoprotein, such as ritonavir, clarithromycin, diltiazem, or verapamil. Participants will also be asked to avoid grapefruit juice while taking the study drug.

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 15 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: Binita Shah, MD, VA NY Harbor Healthcare System, New York, NY

Phone: (718) 836-6600

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
21 August 2023
Est. completion
31 July 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Major adverse cardiovascular events

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: 15 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