Role of Alprazolam in the Management of Acute Coronary Syndrome

Overview

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 Title of Study: “Effect of Alprazolam on Heart Rate and Acute Inflammatory Marker in Acute Coronary Syndrome Patients”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Study Primary Completion Date: November 15, 2021

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.

Interventions

• Drug: Alprazolam
  • Alprazolam 0.5 mg will be given when the patient with acute coronary syndrome would present to the emergency
• Other: Placebo
  • Empty capsule

Arms, Groups and Cohorts

• Experimental: Alprazolam Arm
  • 0.5mg Alprazolam will be given to the patient at the time of presentation
• Placebo Comparator: Placebo Arm
  • The empty capsule will be given to the patient at the time of presentation

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Sohaib Ashraf
• Provider of Information About this Clinical Study
  • Sponsor-Investigator: Sohaib Ashraf, Registrar Cardiology – Sheikh Zayed Federal Postgraduate Medical Institute
• Overall Official(s)
  • Qazi Abdul Saboor, MBBS, Study Chair, Shaikh Zayed Post-Graduate Medical Institute
  • Sohaib Ashraf, MBBS, Principal Investigator, Shaikh Zayed Post-Graduate Medical Institute
• Overall Contact(s)
  • Sohaib Ashraf, MBBS, +18573167995, sohaib@skzmdc.edu.pk