CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 70 enrolled
Drug / intervention
Amiloride +1 moredrug
Likely dose
Amiloride 5mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01231165
NCT01231165Phase 3Completed

Comparative Randomized Single-blind Trial of Amiloride in Coronary Heart Disease

University of Carabobo·interventional·Posted Nov 1, 2010·Updated Jun 11, 2012

In Brief

A Phase 3 clinical trial evaluating Amiloride and Nitrates, clopidogrel, aspirin, statins for Coronary Heart Disease. Completed, enrolled 70 participants across 1 site.

Detailed Summary

Treatment of coronary artery disease is a major health care problem across the entire word, and the United States. Unfortunately, despite a number of medical advances, diagnostic procedure, or epidemiological studies, the treatment of these patients remain complex, and and at times frustrating. In fact, the COURAGE trial conducted in 50 centers across United States and Canada documented that drug treatment, coronary interventions or both were not effective solution in coronary artery diseases. A novel approach has recently been developed, based on the critical role of the potassium (K) content in red-blood-cell in myocardial oxygenation, since oxygen and K binding by hemoglobin (red-blood-cell) occurs simultaneously in blood passing through the lungs, whereas in the organs as the heart, the hemoglobin release both Oxygen and K ions. This apparently simple mechanisms occurs in human blood in all individuals but could be altered in subjects with acquired or hereditable defect in red-blood-cell K content. The purpose of this trial, thus, will be to evaluate the pharmacological effects of Amiloride on RBC K-uptake and transport and its impact on reversion of angina, electrocardiographic changes of myocardial ischemia and electrical regeneration of the heart in subjects with coronary artery diseases.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesVenezuela

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 1, 2010
Enrollment StartFeb 1, 2009
Primary CompletionMay 1, 2010
Study CompletionFeb 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 15.7 years ago

Interventions

Amiloridedrug

5mg/daily for 12th months

Nitrates, clopidogrel, aspirin, statinsdrug

Comparative Efficacious Research