Role of Alprazolam in the Management of Acute Coronary Syndrome

Study Overview
=================
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.

Official Title
-----------------
Effect of Alprazolam on Heart Rate and Acute Inflammatory Marker in Acute Coronary Syndrome Patients

Conditions
-----------------
Anxiety, Acute Coronary Syndrome, Myocardial Infarction, ST Elevation Myocardial Infarction, Heart Diseases

Intervention / Treatment
-----------------
* Drug: Alprazolam
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Systolic BP>100mm Hg Age between 18-80 years Sinus Rhythm Exclusion Criteria: Cardiogenic Shock / Hypotension Known Asthma/COPD Bradycardia (HR < 60) Already on Beta blockers/ Anxiolytics Sick sinus syndrome Second or third-degree heart block (in the absence of pacemaker) Decompensated heart failure With documented hypersensitivity to the drug or components Valvular Heart Diseases Congenital Heart Diseases Status post CABG Any co-morbidities except Diabetes Mellitus and Hypertension

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This randomized, close label, placebo-controlled study with superiority framework as add-on therapy in ACS patients
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alprazolam Arm<br>0.5mg Alprazolam will be given to the patient at the time of presentation | Drug: Alprazolam<br>* Alprazolam 0.5 mg will be given when the patient with acute coronary syndrome would present to the emergency<br>|
| Placebo Comparator: Placebo Arm<br>The empty capsule will be given to the patient at the time of presentation | Other: Placebo<br>* Empty capsule<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Rate | Heart Rate reduction | upto 72 hours | 
| Duration of Hospital stay | Number of days | upto 14 days | 
| Mortality | death of patients | upto 14 days | 
| recurrent symptomatic ischemia | episodes of angina | 72 hours | 
| erythrocyte sedimentation rate (ESR) | Acute phase reactants | upto 72 hours | 
| C-reactive protein (CRP) | Acute phase reactants | upto 72 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiology, Acute Coronary Syndrome, Heart Rate, Alprazolam, Anxiolytic