Clinical trial NCT01404078: Study to Compare 2 Doses of Polycap Versus Single Dose of Polycap With or Without Pottasium
Official title: A RCT With Factorial Design to Compare Safety and Efficacy of 2 Capsules of the Indian Polycap Versus a Single Capsule Along With or Without Oral Potassium Among Patients With Stable Cardiovascular Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Heart Disease
Ischemic Stroke
Peripheral Vascular Disease
Type 2 Diabetes Mellitus
Lead sponsor: St. John's Research Institute
Sponsor class: OTHER
Collaborators: name: Population Health Research Institute
First posted: 2011-07-27
Enrollment: 518
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized double blind 2x2 factorial controlled trial to evaluate efficacy tolerability of low strength Polycap versus two doses of low strength Polycap in patients with stable cardiovascular disease in reducing blood pressure and LDL.

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: Mean change in blood pressure between those taking 2capsules of the polycap versus one Difference in Rates of early discontinuation between 2 capsules of polycap versus one Rates of reported adverse effects among those taking the polycap

Eligibility criteria: Inclusion Criteria:

1. Individuals 40 years and above, with a seated blood pressure \> 130/80 mm Hg on two consecutive readings (or BP \> 120/80 mm Hg in patients under treatment with 2 or more antihypertensive medication) with one of the following

   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:

1. Known hypersensitivity or intolerance to any of the study medications or a clear indication for full doses of beta blockers, RAAS blockers (ACEi, ARBs, Renin inhibitors, etc.), diuretics and statins.
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.).

Primary outcomes:
measure: BLOOD PRESSURE LIPIDS
timeFrame: 8 weeks
measure: Tolerability of a Double Dose of Half Strength Polycap
timeFrame: 8 weeks
Secondary outcomes:
measure: Blood Pressure Reduction and Lipid Lowering in Type 2 Diabetics
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: St.Johns Research Institute
name: Dr.Prem - Pais, MD
role: PRINCIPAL_INVESTIGATOR
References: