Recruiting PHASE2 Acute Coronary Syndrome

New treatment option for Acute Coronary Syndrome

Official title Effect of Colchicine on Coronary Reperfusion in Patients With Acute Coronary Syndrome

ClinicalTrials.gov ID: NCT05472337

What this study is testing

What is Colchicine?

Colchicine is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for acute coronary syndrome.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
This randomized clinical trial will determine the treatment effect of colchicine (1.5 mg loading dose and 0.5 mg daily thereafter) for 6 weeks on microvascular coronary reperfusion and infarct size in patients with acute coronary syndrome.
  • Phase 2: a mid-size study of how well it works
  • You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • Age ≥18 years.
  • Adults hospitalized at the Clinical Hospital of the Catholic University for an ACS condition, defined as: \- Presence of chest pain, associated with...
  • Patients undergoing coronary angiography with the intention of angioplasty in the next few days (during the index hospitalization).
  • Ability and willingness to provide written informed consent.

You likely can't join if

  • ST-segment elevation myocardial infarction (undergoing emergency angioplasty therefore not allowing time for the administration and effect of...
  • Severe left main stenosis.
  • Advanced heart failure, left ventricular ejection fraction \<35%.
  • Related to colchicine use: known intolerance, previous use for another condition (e.g., gout), severe liver disease (e.g., severe liver disease).
  • Severe liver disease (transaminase elevation 3 times above normal), blood dyscrasia (leukocyte or platelet count lower than normal), glomerular...
  • Any other disease that limits life expectancy to \<1 year.
See the full eligibility criteria
Who can join
  • Age ≥18 years.
  • Adults hospitalized at the Clinical Hospital of the Catholic University for an ACS condition, defined as: \- Presence of chest pain, associated with enzymatic elevation (increase of ultrasensitive troponin above normal...
  • Patients undergoing coronary angiography with the intention of angioplasty in the next few days (during the index hospitalization).
  • Ability and willingness to provide written informed consent.
What rules you out
  • ST-segment elevation myocardial infarction (undergoing emergency angioplasty therefore not allowing time for the administration and effect of colchicine).
  • Severe left main stenosis.
  • Advanced heart failure, left ventricular ejection fraction \<35%.
  • Related to colchicine use: known intolerance, previous use for another condition (e.g., gout), severe liver disease (e.g., severe liver disease).
  • Severe liver disease (transaminase elevation 3 times above normal), blood dyscrasia (leukocyte or platelet count lower than normal), glomerular filtration rate (MDRD), use of CYP3A4 or calcineurin inhibitors, active...
  • Any other disease that limits life expectancy to \<1 year.
  • Medical history of a disorder that could, in the opinion of the treating physician, place the participant at significant risk if they were to participate in the trial.

The study team makes the final eligibility decision.

Where it's taking place

  • Santiago, Santiago Metropolitan, Chile

Compensation & support

Compensation mentioned.

ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.

Questions & answers

Do participants get paid in this trial?

This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Santiago, Santiago Metropolitan, Chile. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.