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Evaluation of anti-inflammatory effects of colchicine on the blood flow of heart's vessels and heart's muscle in patients who undergo angioplasty in the acute phase of heart attack

Anti-inflammatory Effects of Colchicine on Thrombolysis in myocardial infarction (TIMI) flow grade, Myocardial Perfusion Grade (MPG) and no-reflow rate in patients undergoing Primary Percutaneous coronary intervention (PCI) in acute MI phase

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20120111008698N23
Enrollment
320
Registered
2018-07-15
Start date
2018-02-26
Completion date
Unknown
Last updated
2018-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute myocardial infarction. ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction

Interventions

Intervention 1: Intervention group: Oral colchicine (Modava, Tehran) 1mg followed by 0.5 mg after PCI. Intervention 2: Control group: Placebo of colchicine was administered at the dose of 1 mg followe

Sponsors

Deputy of Research and Technology of Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who are candidates for the Primary PCI Pain or chest discomfort greater than or equal to 20 minutes, less than or equal to 12 hours, and ST elevation = 1 mm in the adjacent limb leads and precordial leads except for V2, V3, or ST elevation = 2 mm in V2, V3 in men or ST height = 1.5 mm in V2, V3 in women. Obtain informed consent from all patients before enrollment

Exclusion criteria

Exclusion criteria: Patients who are only undergoing angiography for diagnostic purposes and do not undergo PCI Patients who have been treated with Colchicine due to chronic illness Colchicine intolerance history Glumerolar filtration Rate less than 30 ml/min and Dialysis patients Malignancy and infection Oral steroids or NSAIDs ( Except for aspirin) within 72 hours prior to PCI Use of CYP 3A4 / P-glycoprotein inhibitor drugs (Ritonavir / Ketoconazole / Clarithromycin / Cyclosporine / Diltiazem / Vrapaemia) Patients who suffered cardiac arrest, cardiogenic shock (systolic pressure less than 90), VF, or under CPR in emergency setting Start angina more than 12 hours

Design outcomes

Primary

MeasureTime frame
Coronary blood flow and myocardial perfusion. Timepoint: during angiography. Method of measurement: TIMI flow criteria and observations during the angiography.

Secondary

MeasureTime frame
Hs-CRP. Timepoint: baseline and 48 hours after PCI. Method of measurement: blood sample.;TNT. Timepoint: baseline and 6 hours and 24 hours and 48 hours after PCI. Method of measurement: blood sample.;P-selectin. Timepoint: baseline and 24 hours after PCI. Method of measurement: blood sample.;30 day MACE. Timepoint: one month after PCI. Method of measurement: follow-up visit or phone call.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr.Seyed Hossein Hosseini

Tehran University of Medical Sciences

hossein5859@yahoo.com+98 21 8802 9261

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 12, 2026