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Colchicine Versus Beta-blockers, Angiotensin-converting Enzyme Inhibitors, and Statins for Prevention of Chemotherapy-Induced Cardiomyopathy

NCT06304896 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2024-03-12

No results posted yet for this study

Summary

BASiC-CIC Trial is a multicenter, double-blinded, randomized, placebo-controlled clinical trial to investigate whether repurposing colchicine or a combination of beta-blockers, angiotensin-converting enzyme (ACE) inhibitors, and statins will be effective as a prophylactic treatment for the prevention of chemotherapy-induced cardiomyopathy, reduction of major adverse cardiovascular events, and all-cause mortality.

Conditions

  • Chemotherapy Induced Systolic Dysfunction

Interventions

DRUG

Carvedilol

Carvedilol 6.25 mg oral tablets. Prescribed: Twice daily PO with 200 mL of water.

DRUG

Ramipril

Ramipril 2.5 mg oral capsules. Prescribed: Once daily PO with 200 mL of water.

DRUG

Rosuvastatin

Rosuvastatin 20 mg oral tablets. Prescribed: Once daily PO with 200 mL of water.

DRUG

Colchicine

Colchicine 0.6 mg oral tablets/capsules. Prescribed: Once daily PO with 200 mL of water.

DRUG

Placebo

Placebo oral capsules. Prescribed: Once daily PO with 200 mL of water.

Sponsors & Collaborators

  • Arab Contractors Medical Centre

    lead OTHER

Principal Investigators

  • Eslam Abbas, MBChB, MSc · Arab Contractors Medical Centre

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-01
Primary Completion
2025-05-01
Completion
2025-12-01

Countries

  • Egypt

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06304896 on ClinicalTrials.gov