Colchicine in Periprocedural Myocardial Infarction: the Role of Alpha Defensin

Hillel Yaffe Medical Center

Status: Unknown

Conditions: Inflammation; Myocardial Infarction

Treatments: Drug: Standard of care treatment prior to elective PCI; Drug: Colchicine Loading Dose

Study type: Interventional

Funder types: Other

Identifiers

NCT03735134

HYMC-99-18

Details and patient eligibility

About

The aim of this research is to study the effect of a loading dose of colchicine on the occurrence of periprocedural myocardial infarction (PPMI) in elective percutaneous coronary intervention.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients hospitalized with troponin negative events and scheduled for elective PCI

Exclusion criteria

• Significant renal dysfunction
• Significant liver dysfunction
• Severe left ventricular dysfunction
• Severe low weight
• Chronic colchicine treatment

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

180 participants in 3 patient groups

Control Group

Active Comparator group

Description:

Stable coronary artery disease patients who have been assigned to elective PCI and who will be given standard of care treatment

Treatment:

Drug: Standard of care treatment prior to elective PCI

Early colchicine loading dose

Active Comparator group

Description:

Stable coronary artery disease patients who have been assigned to elective PCI and who will be given standard of care treatment plus colchicine loading dose 12-24 hours before PCI

Treatment:

Drug: Colchicine Loading Dose

Late colchicine loading dose

Active Comparator group

Description:

Stable coronary artery disease patients who have been assigned to elective PCI and who will be given standard of care treatment plus colchicine loading dose one hour prior to PCI

Treatment:

Drug: Colchicine Loading Dose