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

Sohaib Ashraf

Status and phase: Unknown; Phase 2; Phase 1

Conditions: ST Elevation Myocardial Infarction; Acute Coronary Syndrome; Myocardial Infarction; Anxiety; Heart Diseases

Treatments: Drug: Alprazolam; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04715269

SZMC/IRB/0022

Details and patient eligibility

About

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).

Full 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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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48 participants in 2 patient groups, including a placebo group

Alprazolam Arm

Experimental group

Description:

0.5mg Alprazolam will be given to the patient at the time of presentation

Treatment:

Drug: Alprazolam

Placebo Arm

Placebo Comparator group

Description:

The empty capsule will be given to the patient at the time of presentation

Treatment:

Other: Placebo