Novel Treatment for Coronary Artery Disease
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|ClinicalTrials.gov Identifier: NCT01228214|
Recruitment Status : Unknown
Verified March 2013 by Antonio Delgado Leon, MD, University of Carabobo.
Recruitment status was: Active, not recruiting
First Posted : October 26, 2010
Last Update Posted : March 19, 2013
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, as in hypertensives or CAD patients.
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Drug: Placebo Drug: amiloride||Phase 2 Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Randomized Double-Blind Placebo-Controlled Study of Pyrazinoylguanidine Hydrochloride (Amiloride) in Subjects With Coronary Artery Disease|
|Study Start Date :||March 2011|
|Estimated Primary Completion Date :||April 2013|
|Estimated Study Completion Date :||September 2013|
Comparative Efficacious Research
5mg/daily for 12 months
Placebo Comparator: Placebo,nitrates,clopidogrel,aspirin
Comparative Efficacious Research
Placebo 5mg/daily for 12 months
- Regression of Angina Without Recurrence [ Time Frame: Baseline, 1, 3, 6 and 12 Months during the first year trial, and every 6-months in the 2nd year period ]Evaluation of Angina Class according the Canadian Society of Cardiology (CCS)
- Regression of ST-T and T-waves Alterations of Myocardial Ischemia [ Time Frame: Baseline, 1, 3, 6 and 12 Months during the first year trial, and every 6-months in the 2nd year period ]Evaluation according the Minnesota Code
- RBC Potassium Content [ Time Frame: Baseline, 1, 3, 6 and 12 Months during the first year trial, and every 6-months in the 2nd year period ]Obtained by a novel accurate method developed in our laboratory (Nutr Metab Cardiovasc Dis. 2002 Jun;12(3):112-116
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01228214
|Hypertension Research Unit|
|Valencia, Carabobo, Venezuela, 2001|
|Study Chair:||Antonio J Delgado-Leon, MD||University of Carabobo|
|Study Director:||Carlos L Delgado-Leon, MD||Venezuelan Foundation of Heart Failure|
|Principal Investigator:||Antonio R Delgado-Almeida, MD, FAHA, FACC, APS||Clinical Research Unit at Docent Institute of Urology|