Role of Alprazolam in the Management of Acute Coronary Syndrome

Phase 1

• Conditions: Myocardial Infarction; Heart Diseases; Acute Coronary Syndrome; ST Elevation Myocardial Infarction; Anxiety
• Interventions: Other: Placebo; Drug: Alprazolam

• Registration Number: NCT04715269
• Lead Sponsor: Sohaib Ashraf

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 Timeline

• Study Start: 2020-12-25
• Status Verified: 2021-01
• Study First Submitted: 2021-01-15
• Study First Submitted QC: 2021-01-19
• Last Update Submitted: 2021-01-19
• Study First Posted: 2021-01-20
• Last Update Posted: 2021-01-20
• Primary Completion: 2021-11-15
• Study Completion: 2022-02-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Arm	Placebo	The empty capsule will be given to the patient at the time of presentation
Alprazolam Arm	Alprazolam	0.5mg Alprazolam will be given to the patient at the time of presentation

Primary Outcome Measures

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

Trial Locations

Locations (1)

Shaikh Zayed Post-Graduate Medical Institute; 🇵🇰 Lahore, Pakistan