Study to Compare 2 Doses of Polycap Versus Single Dose of Polycap With or Without Pottasium (TIPSK)

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

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.

Study Overview

• Status: Completed
• Conditions: Ischemic Stroke; Type 2 Diabetes Mellitus; Peripheral Vascular Disease; Ischemic Heart Disease
• Intervention / Treatment: Drug: Single Dose Polycap; Drug: Double dose Polycap

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

• Study Type: Interventional
• Enrollment (Actual): 518
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: SD Polycap without potassium; Single dose polycap without pottasium	Drug: Single Dose Polycap; Low strength polycap contains Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin; Other Names: Polycap
Experimental: DD Polycap plus potassium; Double Dose polycap with potassium	Drug: Double dose Polycap; 2 Capsules of low strength polycap with 30mEq of Potassium; Other Names: Full dose polycap

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BLOOD PRESSURE LIPIDS	Amongst patients with cardiovascular disease or type 2 diabetes, the study aims to test the safety and efficacy of giving double dose of polycap versus a single dose of polycap for 8 weeks; efficacy to lower blood pressure and elevated lipids and safety assessed as difference with tolerance to double dose of polycap compared to a single dose.	8 weeks
Tolerability of a Double Dose of Half Strength Polycap		8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Blood Pressure Reduction and Lipid Lowering in Type 2 Diabetics	8 weeks

Collaborators and Investigators

• Sponsor: St. John's Research Institute
• Collaborators: Population Health Research Institute
• Investigators: Principal Investigator: Dr.Prem - Pais, MD, St.Johns Research Institute

Publications and helpful links

Helpful Links

• Pubmed Abstract

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: July 24, 2011
• First Submitted That Met QC Criteria: July 26, 2011
• First Posted (Estimate): July 27, 2011

Study Record Updates

• Last Update Posted (Estimate): December 1, 2014
• Last Update Submitted That Met QC Criteria: November 26, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Endocrine System Diseases; Diabetes Mellitus; Atherosclerosis; Coronary Disease; Stroke; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Diabetes Mellitus, Type 2; Vascular Diseases; Ischemic Stroke; Ischemia; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: TIPS K; CTRI/2010/091/000054 (Registry Identifier: Clinical Trials Registry of India)