The Indian Polycap-K Study (TIPS-K)
- Registration Number
- CTRI/2010/091/000054
- Lead Sponsor
- Cadila Pharmaceuticals India Ltd. Cadila Corporate Campus', Sarkhej - Dholka Road, Bhat, Ahmedabad- 382210
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 500
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
a.Coronary artery disease; previous myocardial infarction (>7 days post uncomplicated MI), or
b.Ischemic heart disease with significant ECG changes or a positive stress test, or
c.Stable angina or unstable angina and with documented evidence of multi-vessel (angiography or ECG or CT angiography) coronary artery disease, or
d.PTCA or CABG Surgery >30 days before informed consent.
e.Cerebrovascular disease; Previous Ischemic stroke or Transient Ischemic Attacks >30 days before informed consent.
f.High risk diabetes mellitus defined as HbA1C >7.5%, with microalbuminuria or blood pressure >140/90 mm Hg.
g.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
a.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.
b.History of bleeding or having hemorrhagic stroke anytime in the past or a need for continued anticoagulation therapy.
c.Patients having indication for higher doses of aspirin (>200 mg) or needing more than 75mg of clopidogrel daily.
d.Have significant bradycardia (heart rate <50 beats/min) or second- or third-degree heart block without a pacemaker.
e.Planned cardiac surgery or PTCA or any non-cardiac surgery <3months of eligibility assessment.
f.Heart transplant recipient.
g.Renal dysfunction defined as serum creatinine >2 mg/dL and/or serum potassium >5.0 mEq/L.
h.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.
i.Hepatic dysfunction, SGOT or SGPT > 3 x ULN.
j.Taking another experimental drug or within 30days of last dose of the experimental drug.
k.Peptic ulcer disease with bleed, or bleeding diathesis.
l.Bronchial asthma or Chronic Obstructive Pulmonary Disease with asthma.
m.Gout, rheumatoid arthritis or other chronic inflammatory disease requiring long-term medications with NSAIDs.
n.Any history of muscular pain, other pathology of the muscles or past history of muscular pain secondary to taking statins or fibrates.
o.Pregnancy or lactating or women of childbearing potential with inadequate contraception.
p.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 & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in mean blood pressureTimepoint: 8 weeks;Change in micoralbuminuriaTimepoint: 8 weeks;Change in serum Low density Lipoprotein and total cholesterolTimepoint: 8 weeks;Tolerance of 2 doses of low strength polycapTimepoint: 12 weeks;tolerance of potassium citrateTimepoint: 12 weeks
- Secondary Outcome Measures
Name Time Method Efficacy of lowering mean blood pressure in patients with history of diabetesTimepoint: 8 weeks;Efficacy of potassium to lower mean blood pressureTimepoint: 8 weeks