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Clinical trial

Role of Alprazolam in the Management of Acute Coronary Syndrome (A-ACS-PK)

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Last updated:19th Jan 2021
Status: Recruiting
Identifier: NCT04715269
Role of Alprazolam in the Management of Acute Coronary Syndrome (A-ACS-PK)

Brief Summary:
Cardiovascular disease has always been one of the most concerning ailments of all times considering mortality. On one end due to the emergence of pharmaceutical technology, there is a reduction in mortality, on the other hand owing to a sedentary lifestyle the incidence of this disease is increasing. Hence leading to up slopping trend in cardiovascular prevalence. Acute coronary syndrome is one of the most deadly and acute presentations of cardiology requiring immediate intervention to dampen the frequency of complications. One of the fundamental goals in the treatment of ACS is to lower the heart rate so that load on myocardial tissue can be reduced. In order to do so, we already have multiple options like beta-blockers, calcium channel blockers, and new generation ivabradine (not affecting blood pressure unlike others).

Detailed Description:
World has studied the increased prevalence of anxiety as a concomitant factor in ACS patients causing detrimental effects on cardiovascular outcomes being anxiety as one of the first responses to chest pain and hospital admission causing tachycardia. This study is designed to achieve the goals of lowering the heart using the anxiolytic property of alprazolam. This randomized, parallel group, close label, placebo-controlled, event driven, interventional clinical superiority study will be conducted in Cardiology department of Shaikh Zayed Hospital with a sample size of 48 allocating using lottery method in both experimental and control group. Heart Rate at baseline and after 6 hours will be monitored in both groups to establish the fall of heart rate in both patients. Data will be collected by using pre-designed performa and will be entered and analyzed via SAS 9.4. Statistical analysis will be done using T-test and p value <0.05 will be considered significant.

Significance of the study is to lower the required dosage of beta-blockers in order to achieve optimum beta-blockade using an anxiolytic while not affecting the blood pressure.

Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This randomized, close label, placebo-controlled study with superiority framework as add-on therapy in ACS patients
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Masking will be done for all participants
Primary Purpose: Treatment
Official Title: Effect of Alprazolam on Heart Rate and Acute Inflammatory Marker in Acute Coronary Syndrome Patients
Actual Study Start Date: December 25, 2020
Estimated Primary Completion Date: November 15, 2021
Estimated Study Completion Date: February 20, 2022

- Experimental: Alprazolam Arm
- Placebo Comparator: Placebo Arm

Category Value
Study type(s) Interventional
Estimated enrolment 48
Actual Study start date 25 December 2020
Estimated Study Completion Date 20 February 2022

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