NCT06426537CompletedEarly phase 1
Colchicine's Efficacy in MI Patients: Comparing PCI and Non-Reperfusion Approaches
A Comparative Study of Colchicine's Role in Reducing Cardiac Fibrosis in Acute Myocardial Infarction Patients: Evaluating Outcomes With Percutaneous Coronary Intervention Versus Without Reperfusion
Source: ClinicalTrials.gov · Last updated 24 May 2024
Brief summary (registry, in English)
This study investigates the effect of Colchicine in preventing heart structure changes following ST-segment elevation myocardial infarction. Through a clinical trial involving patients requiring coronary intervention, we explore how Colchicine can reduce inflammation and fibrosis, two crucial factors influencing heart failure post-heart attack. The outcomes are expected to offer new insights into post-heart attack treatments to prevent heart failure.
- Status (registry)
- Completed
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 63 (actual)
- First submitted
- 17 May 2024
- Start date
- 20 Oct 2022
- Primary completion date
- 25 Mar 2023
- Lead sponsor
- University of Brawijaya
- Diseases
- Coronary artery disease
- NCT number
- NCT06426537
What you commit to
- Study type: Interventional · Early phase 1
- Participants enrolled: 63
- From 20 Oct 2022 to the primary completion date, 25 Mar 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Presence of concurrent diseases such as infections, inflammation, or malignancy.
Other illness
- Diagnosed with gastrointestinal disorders including Crohn's disease, ulcerative colitis, or exhibiting chronic diarrhea.
Lab values
- Recent abnormal laboratory results (within the last 30 days) including:
- Hemoglobin below 11.5 g/L Leukocytes below 3.0 x 10\^9/L Platelets below 110 x 10\^9/L ALT more than three times the upper limit of normal Total bilirubin more than twice the upper limit of normal Creatinine more than twice the upper limit of normal History of liver cirrhosis, acute hepatitis exacerbation, or severe liver disease.
- History of alcohol abuse. Receiving long-term steroid therapy or using colchicine for other indications. History of hypersensitivity to colchicine. Severe renal failure (eGFR below 30). History of cardiac arrest, ventricular fibrillation, cardiogenic shock, or hemodynamic instability.
Other
- Currently pregnant, breastfeeding, or planning to become pregnant during the study.
- Unwilling or unable to provide informed consent.
Who the study is looking for
- Men and women aged 18 years or older. Able and willing to provide informed consent. Presenting with clinical symptoms and supporting examinations indicative of a first-time diagnosis of IMA-EST.
- Eligible for treatment according to the IMA-STEMI guidelines, which may include:
- Antiplatelet therapy Renin-angiotensin-aldosterone system inhibitors Beta-blockers
- Specifically, includes patients who have:
- Undergone early PCI. Not received reperfusion therapy. Female patients must commit to avoiding pregnancy during the study. Willing to participate in follow-up via face-to-face or telephone contact.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tri Astiawati Coordinator of this site? Confirm its status | Tulungagung | Indonesia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.