Study to Compare 2 Doses of Polycap Versus Single Dose of Polycap With or Without Pottasium
NCT ID: NCT01404078
Last Updated: 2014-12-01
Study Results
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View full resultsBasic Information
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COMPLETED
NA
518 participants
INTERVENTIONAL
2010-04-30
2011-02-28
Brief Summary
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To evaluate the tolerability and safety of low dose potassium supplementation compared to placebo in patients with stable cardiovascular disease.
Approximately 500 patients are planned to be randomized.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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SD Polycap without potassium
Single dose polycap without pottasium
Single Dose Polycap
Low strength polycap contains Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin
DD Polycap plus potassium
Double Dose polycap with potassium
Double dose Polycap
2 Capsules of low strength polycap with 30mEq of Potassium
Interventions
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Single Dose Polycap
Low strength polycap contains Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin
Double dose Polycap
2 Capsules of low strength polycap with 30mEq of Potassium
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Coronary artery disease; previous myocardial infarction (\>7 days post uncomplicated MI), or
2. Ischemic heart disease with significant ECG changes or a positive stress test, or
3. Stable angina or unstable angina and with documented evidence of multi-vessel (angiography or ECG or CT angiography) coronary artery disease, or
4. PTCA or CABG Surgery \>30 days before informed consent.
5. Cerebrovascular disease; Previous Ischemic stroke or Transient Ischemic Attacks \>30 days before informed consent.
6. High risk diabetes mellitus defined as HbA1C \>7.5%, with microalbuminuria or blood pressure \>140/90 mm Hg.
7. Peripheral artery disease defined as a current or prior history of: physician diagnosed intermittent claudication or vascular surgery for atherosclerotic disease or an ankle/arm systolic blood pressure ratio ≤ 0.90 in either leg at rest, or angiographic or doppler study demonstrating ≥ 70% stenosis in a noncardiac artery.
2. Those who provide informed consent and can comply with medications and follow-up visits.
Exclusion Criteria
2. History of bleeding or having hemorrhagic stroke anytime in the past or a need for continued anticoagulation therapy.
3. Patients having indication for higher doses of aspirin or needing more than 75mg of clopidogrel daily.
4. Have significant bradycardia (heart rate \<50 beats/min) or second- or third-degree heart block without a pacemaker.
5. Planned cardiac surgery or PTCA or any non-cardiac surgery \<3months of eligibility assessment.
6. Heart transplant recipient.
7. Renal dysfunction defined as serum creatinine \>2 mg/dL and/or serum potassium \>5.0 mEq/L.
8. Patients aged \>70 years, with mild renal dysfunction defined as serum creatinine \>124 µmol/L (1.4 mg/dL) or eGFR \<45 ml/min/1.73 m2.
9. Hepatic dysfunction, SGOT or SGPT \> 3 x ULN.
10. Taking another experimental drug or within 30days of last dose of the experimental drug.
11. Peptic ulcer disease with bleed, or bleeding diathesis.
12. Bronchial asthma or Chronic Obstructive Pulmonary Disease with asthma.
13. Gout, rheumatoid arthritis or other chronic inflammatory disease requiring long-term medications with NSAIDs.
14. Any history of muscular pain, other pathology of the muscles or past history of muscular pain secondary to taking statins or fibrates.
15. Pregnancy or lactating or women of childbearing potential with inadequate contraception.
16. Inability to attend follow up visits (due to significant disability, inadequate address or contact details, subject from a far off place, psychiatric illness etc.).
40 Years
ALL
No
Sponsors
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Population Health Research Institute
OTHER
St. John's Research Institute
OTHER
Responsible Party
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Principal Investigators
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Dr.Prem - Pais, MD
Role: PRINCIPAL_INVESTIGATOR
St.Johns Research Institute
Related Links
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Pubmed Abstract
Other Identifiers
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CTRI/2010/091/000054
Identifier Type: REGISTRY
Identifier Source: secondary_id
TIPS K
Identifier Type: -
Identifier Source: org_study_id