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.
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 不适用
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
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
- Coronary artery disease; previous myocardial infarction (>7 days post uncomplicated MI), or
- Ischemic heart disease with significant ECG changes or a positive stress test, or
- Stable angina or unstable angina and with documented evidence of multi-vessel (angiography or ECG or CT angiography) coronary artery disease, or
- PTCA or CABG Surgery >30 days before informed consent.
- Cerebrovascular disease; Previous Ischemic stroke or Transient Ischemic Attacks >30 days before informed consent.
- High risk diabetes mellitus defined as HbA1C >7.5%, with microalbuminuria or blood pressure >140/90 mm Hg.
- 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.
- Those who provide informed consent and can comply with medications and follow-up visits.
Exclusion Criteria:
- 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.
- History of bleeding or having hemorrhagic stroke anytime in the past or a need for continued anticoagulation therapy.
- Patients having indication for higher doses of aspirin or needing more than 75mg of clopidogrel daily.
- Have significant bradycardia (heart rate <50 beats/min) or second- or third-degree heart block without a pacemaker.
- Planned cardiac surgery or PTCA or any non-cardiac surgery <3months of eligibility assessment.
- Heart transplant recipient.
- Renal dysfunction defined as serum creatinine >2 mg/dL and/or serum potassium >5.0 mEq/L.
- 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.
- Hepatic dysfunction, SGOT or SGPT > 3 x ULN.
- Taking another experimental drug or within 30days of last dose of the experimental drug.
- Peptic ulcer disease with bleed, or bleeding diathesis.
- Bronchial asthma or Chronic Obstructive Pulmonary Disease with asthma.
- Gout, rheumatoid arthritis or other chronic inflammatory disease requiring long-term medications with NSAIDs.
- Any history of muscular pain, other pathology of the muscles or past history of muscular pain secondary to taking statins or fibrates.
- Pregnancy or lactating or women of childbearing potential with inadequate contraception.
- Inability to attend follow up visits (due to significant disability, inadequate address or contact details, subject from a far off place, psychiatric illness etc.).
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器:SD Polycap without potassium
Single dose polycap without pottasium
|
Low strength polycap contains Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin
其他名称:
|
|
实验性的:DD Polycap plus potassium
Double Dose polycap with potassium
|
2 Capsules of low strength polycap with 30mEq of Potassium
其他名称:
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
BLOOD PRESSURE LIPIDS
大体时间:8 weeks
|
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
大体时间:8 weeks
|
8 weeks
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Blood Pressure Reduction and Lipid Lowering in Type 2 Diabetics
大体时间:8 weeks
|
8 weeks
|
合作者和调查者
调查人员
- 首席研究员:Dr.Prem - Pais, MD、St.Johns Research Institute
出版物和有用的链接
有用的网址
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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