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The rationale of MIDA trial is to determine efficacy and tolerability of ranolazine molecule among Pakistan population and obtain firsthand knowledge about the molecule ranolazine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ranolazine | Other | Ranolazine was approved by the U.S. Food and Drug Administration in 2006 in 500 mg and 1000 mg extended-release doses, advising 500 mg BID as a starting dose and 1000 mg BID as maximum dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranolazine | Drug | Ranolazine inhibits sodium and potassium ion channel currents. Inhibition of the late phase of the inward sodium current during cardiac repolarization has been well studied4. In disease states, enhanced sodium-calcium exchange due to augmented late phase of the inward sodium current activity leads to increased cytosolic calcium concentration. Intracellular calcium overload is believed to be critical to the mechanism of decreased left ventricular relaxation caused by ischemia and reperfusion. Elevated left ventricular diastolic wall tension compromises myocardial blood flow even further. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: Reduction in frequency of Angina with Ranolazine | To determine reduction in frequency of Angina with Ranolazine | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Proportion of participants experiencing an adverse event (AE) | Proportion of participants experiencing an adverse event (AE) | 24 weeks |
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Inclusion Criteria:
Patients with diagnosis of coronary artery disease (CAD)
Exclusion Criteria:
• Factors that might compromise ECG or ETT interpretation
Patients with resting ST-segment depression ≥ 1mm in any lead
Left bundle-branch block
Patients implanted with pacemaker
Patients under Digitalis therapy
*Other than those who have been surgically sterilized (defined as having undergone hysterectomy or bilateral oophorectomy or bilateral salpingectomy; tubal ligation alone is not considered sufficient) or one year post-menopausal.
• Patients are under any one of the following conditions:
New York Heart Association (NYHA) Class III or Class IV congestive heart failure (CHF)
QTc > 450 msec at screening
Active myocarditis, pericarditis, hypertrophic cardiomyopathy
Uncontrolled hypertension (defined as SBP > 180 mmHg) Voltage criteria for left ventricular hypertrophy in the absence of repolarization abnormalities will not be exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Faizan Shaukat | Contact | +923328814816 | faizan.shaukat@obs.com.pk |
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| ID | Term |
|---|---|
| D060050 | Angina, Stable |
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000069458 | Ranolazine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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Open Labelled Phase IV clinical trial
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|
| D002637 |
| Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |