The Indian Polycap-K Study (TIPS-K)

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2010
INTERVENTION: Intervention1: POLYCAP: ASPIRIN 100mg ATENOLOL 50MG RAMIPRIL 5MG HYDROCHLOROTHIAZIDE 12.5mg SIMVASTATIN 20mg Intervention2: Potassium citrate: 30 mEq once a day Control Intervention1: 2 capsules of POLYCAP: SAME AS INTERVENTION BUT 2 CAPSULES Control Intervention2: no potassium supplementation: Not applicable CONDITION: Cardiovascular disease secondary prevention therapy. PRIMARY OUTCOME: Change in mean blood pressure‐‐‐‐‐‐Timepoint: 8 weeks Change in micoralbuminuria‐‐‐‐‐‐Timepoint: 8 weeks Change in serum Low density Lipoprotein and total cholesterol‐‐‐‐‐‐Timepoint: 8 weeks Tolerance of 2 doses of low strength polycap‐‐‐‐‐‐Timepoint: 12 weeks tolerance of potassium citrate‐‐‐‐‐‐Timepoint: 12 weeks SECONDARY OUTCOME: Efficacy of lowering mean blood pressure in patients with history of diabetes‐‐‐‐‐‐Timepoint: 8 weeks Efficacy of potassium to lower mean blood pressure‐‐‐‐‐‐Timepoint: 8 weeks INCLUSION 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 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: phy
Epistemonikos ID: bc4a75127ff7e9161948436546fc4553ac2cea1c
First added on: Aug 22, 2024