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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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25 March 2013 |
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Main ID: |
NCT01228214 |
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Date of registration:
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25/10/2010 |
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Primary sponsor: |
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Public title:
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Novel Treatment for Coronary Artery Disease
No |
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Scientific title:
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Randomized Double-Blind Placebo-Controlled Study of Pyrazinoylguanidine Hydrochloride (Amiloride) in Subjects With Coronary Artery Disease |
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Date of first enrolment:
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March 2011 |
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Target sample size:
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100 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01228214 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Countries of recruitment
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Venezuela
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Contacts
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Name:
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Antonio R Delgado-Almeida, MD, FAHA, FACC, APS |
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Address:
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Telephone:
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Email:
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Affiliation:
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Clinical Research Unit at Docent Institute of Urology |
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Name:
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Antonio J Delgado-Leon, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Carabobo |
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Name:
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Carlos L Delgado-Leon, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Venezuelan Foundation of Heart Failure |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Male or female, age 35-75 years having angina (Canada Cardiovascular Society Class
II-IV)
2. Essential Hypertension defined as taking at least 1 anti-hypertensive medication, or
average systolic blood pressure =140 mm Hg, or diastolic blood pressure =90 mmHg
3. ST-T changes of LVH (Romhilt-Estes or Framingham Heart Study criteria, with typical
LV strain pattern, or isoelectric, inverted or biphasic T waves)
4. ST-T changes of ischemia in resting ECG (ST depression, isoelectric, biphasic,
negative or inverted T-waves)
5. Serum potassium < 5.0 mmol/L prior to randomization
6. Negative pregnancy test in child-bearing potential women
7. Willing to comply with scheduled visits
8. Informed consent form signed by the subject
Exclusion Criteria:
1. Resistance hypertension despite 3-drugs treatment
2. Myocardial infarction in past 90 days
3. Coronary artery bypass graft surgery in past 90 days
4. Atrial fibrillation with a resting heart rate > 90 bpm
5. Percutaneous coronary intervention in past 30 days
6. Implanted Pacemaker
7. Stroke in past 90 days
8. Left or Right Ventricular Branch Block
9. Aldosterone antagonist or K sparing drug in last 7 days
10. Intolerance to amiloride
11. Lithium use
12. Current participation in any other therapeutic trial
13. Any condition that may prevent the subject from adhering to the trial protocol
14. History of hyperkalemia (K =5.5 mmol/L) in the past six months or K >5.0 mmol/L
within 2 weeks
15. Chronic renal dysfunction
16. Liver disease
17. Chronic pulmonary disease
18. Significant uncorrected valvular heart disease
Age minimum:
35 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Coronary Artery Disease
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Intervention(s)
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Drug: amiloride
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Drug: Placebo
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Primary Outcome(s)
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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]
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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]
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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]
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Secondary ID(s)
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UIC-3 2007
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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