Role of Alprazolam in the Management of Acute Coronary Syndrome

Anxiety Clinical Trial

— A-ACS-PK  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04715269
• Other study ID #: SZMC/IRB/0022
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: December 25, 2020
• Est. completion date: February 20, 2022

Study information

• Verified date: January 2021
• Source: Sheikh Zayed Federal Postgraduate Medical Institute
• Contact: Sohaib Ashraf, MBBS
• Phone: +18573167995
• Email: sohaib[@]skzmdc.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: February 20, 2022
• Est. primary completion date: November 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Anxiety
• Heart Diseases
• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Pakistan	Shaikh Zayed Post-Graduate Medical Institute	Lahore

Sponsors (1)

Lead Sponsor	Collaborator
Sohaib Ashraf

Country where clinical trial is conducted

Pakistan, 

Outcome

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