Ischemic Heart DiseaseTIPSKNCT01404078
Study to Compare 2 Doses of Polycap Versus Single Dose of Polycap With or Without Pottasium
A study testing Single Dose Polycap and Double dose Polycap in people with Ischemic Heart Disease and Ischemic Stroke, run by St. John's Research Institute.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Ischemic Heart Disease, Ischemic Stroke, Peripheral Vascular Disease
- What is being tested?
- Single Dose Polycap and Double dose Polycap
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 518 participants
- Where
- No sites listed yet
- Study dates
- Apr 2010to Feb 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.).
About this study
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
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.
Read the 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
- Conditions
- Ischemic Heart Disease, Ischemic Stroke, Peripheral Vascular Disease, Type 2 Diabetes Mellitus
- Being tested
- Single Dose Polycap, Double dose Polycap
- Medical subject headings
- Myocardial Ischemia, Ischemic Stroke, Peripheral Vascular Diseases, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Dose PolycapDrug
Also called Polycap
Low strength polycap contains Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin
Double dose PolycapDrug
Also called Full dose polycap
2 Capsules of low strength polycap with 30mEq of Potassium
| Study group | Role | What they receive |
|---|---|---|
| SD Polycap without potassium | Active comparator | Single dose polycap without pottasium Receives: Drug: Single Dose Polycap |
| DD Polycap plus potassium | Experimental | Double Dose polycap with potassium Receives: Drug: Double dose Polycap |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Tolerability of a Double Dose of Half Strength Polycap
Measured: 8 weeks
Secondary outcomes (1)
Blood Pressure Reduction and Lipid Lowering in Type 2 Diabetics
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2011 (estimated)
- Study startApr 2010
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 518 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. John's Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Population Health Research Institute
- Responsible party
- Sponsor
- Investigators
- Dr.Prem - Pais, MD, Principal investigator, St.Johns Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01404078
- Sponsor's protocol ID
- TIPS K
- Other IDs
- CTRI/2010/091/000054
- Acronym
- TIPSK
- Status last verified
- Nov 2014
- First submitted
- 24 Jul 2011
- Last updated
- 1 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01404078
- Acronym / sponsor ID
- TIPSK / TIPS K
- Conditions
- Ischemic Heart Disease, Ischemic Stroke, Peripheral Vascular Disease, Type 2 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 518 participants (actual)
- Lead sponsor
- St. John's Research InstituteUniversity, hospital or other
- Collaborators
- Population Health Research Institute
- Study start
- Apr 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 27 Jul 2011 (estimated)
- Results
- Posted 1 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SD Polycap without potassium | Active comparator | Drug: Single Dose PolycapSingle dose polycap without pottasium |
| DD Polycap plus potassium | Experimental | Drug: Double dose PolycapDouble Dose polycap with potassium |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
- Those who provide informed consent and can comply with medications and follow-up visits.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single Dose PolycapAlso: PolycapLow strength polycap contains Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin | Drug | SD Polycap without potassium |
| Double dose PolycapAlso: Full dose polycap2 Capsules of low strength polycap with 30mEq of Potassium | Drug | DD Polycap plus potassium |
Primary outcome
BLOOD PRESSURE LIPIDS
Time frame: 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.
Tolerability of a Double Dose of Half Strength Polycap
Time frame: 8 weeks
1 secondary outcome
Blood Pressure Reduction and Lipid Lowering in Type 2 Diabetics
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Pubmed AbstractLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr.Prem - Pais, MD principal investigator
St.Johns Research Institute
Questions about this trial
What is this clinical trial studying?
A study testing Single Dose Polycap and Double dose Polycap in people with Ischemic Heart Disease and Ischemic Stroke, run by St. John's Research Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BLOOD PRESSURE LIPIDS (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2014.