Phase 4 Heart Disease Trial, Recruiting NCT04240834 Sponsor: Fu Wai Hospital, Beijing, China Condition: Heart Disease
Back to Heart Disease

Phase 4 Heart Disease Trial, Recruiting

NCT04240834
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 who have had a serious heart event (called acute coronary syndrome) and are considered at high risk of future heart problems, and who have had a successful procedure to open blocked arteries (PCI) with at least one drug-coated stent placed
  • People who are willing and able to give their consent to participate and to attend follow-up appointments over 12 months
  • People for whom dual antiplatelet therapy (a combination of blood-thinning medicines to prevent clots) is a suitable treatment option
  • To be eligible, a person must meet at least one clinical or procedure-related (angiographic) criterion listed below, and none of the exclusion criteria

Clinical criteria (at least one must apply):

  • A close blood relative (parent, sibling, or child) who developed heart disease at a young age — before 55 in a male relative or before 65 in a female relative
  • A history of more than one heart attack
  • Blood test results showing elevated heart-damage proteins (cardiac troponin I or T)
  • Hardening or narrowing of arteries in at least one other part of the body, such as the brain or legs
  • Type 2 diabetes that is being managed with medication
  • Reduced kidney function below a certain level (confirm with trial site for exact values)

Procedure-related (angiographic) criteria (at least one must apply):

  • A blockage in the main left heart artery (left main artery) that required a stent
  • A blockage near the top of a major heart artery (proximal LAD) that required a stent
  • A blockage in a bypass graft (from previous heart bypass surgery) that required a stent
  • A total stent length of 60 mm or more across all stents placed
  • A previous history of a blood clot forming inside a stent
  • A branching artery blockage that required two or more stents
  • Blockages in more than two heart arteries that required stents
  • A heavily calcified (hardened) blockage that required a special clearing procedure (atherectomy) before stenting
  • A complication during the procedure where blood flow to the heart became very slow or stopped temporarily (no-reflow or slow-flow)
  • A side branch artery of at least 2 mm that could not have normal blood flow restored during the procedure

Who may not be able to join:

  • People who need to take long-term oral blood-thinning medication (anticoagulants)
  • People who have a disease of the heart muscle (such as hypertrophic, dilated, or restrictive cardiomyopathy)
  • People who have serious irregular heart rhythms requiring an implanted defibrillator (ICD)
  • People who have a long-term lung condition such as COPD, asthma, chronic bronchitis, or heart disease caused by lung problems
  • People who have a serious active infection such as active hepatitis B, active hepatitis C, or HIV/AIDS
  • People who have a blood disorder such as low platelet count, severe anaemia, or leukaemia
  • People who have severe liver disease or kidney failure
  • People who have or have had a cancer diagnosis
  • People who have significant difficulties with memory or thinking (cognitive impairment)
  • People who are unwilling or unable to give their consent or attend follow-up appointments

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 20 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: Haiyan Qian, MD, PhD, Fuwai Hospital, Beijing, China

Phone: +8613811386143

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
Sponsor
Fu Wai Hospital, Beijing, China
Registry
ClinicalTrials.gov
Start date
1 February 2021
Est. completion
1 December 2025

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Major adverse cardiac and cerebral events (MACCEs)

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: 20 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