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

Sponsor

Sohaib Ashraf (Other)

Overall Status

Recruiting

CT.gov ID

NCT04715269

Collaborator

(none)

Enrollment

Location

Arms

13.9

Anticipated Duration (Months)

3.5

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Acute Coronary Syndrome Myocardial Infarction ST Elevation Myocardial Infarction Heart Diseases Anxiety	Drug: Alprazolam Other: Placebo	Phase 1/Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This randomized, close label, placebo-controlled study with superiority framework as add-on therapy in ACS patientsThis randomized, close label, placebo-controlled study with superiority framework as add-on therapy in ACS patients

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Masking will be done for all participants

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 25, 2020

Anticipated Primary Completion Date :

Nov 15, 2021

Anticipated Study Completion Date :

Feb 20, 2022

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Alprazolam Arm

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

Drug: Alprazolam

Alprazolam 0.5 mg will be given when the patient with acute coronary syndrome would present to the emergency

Placebo Comparator: Placebo Arm

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

Other: Placebo

Empty capsule

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shaikh Zayed Post-Graduate Medical Institute	Lahore		Pakistan	54600

Sponsors and Collaborators

Sohaib Ashraf

Investigators

Study Chair: Qazi Abdul Saboor, MBBS, Shaikh Zayed Post-Graduate Medical Institute
Principal Investigator: Sohaib Ashraf, MBBS, Shaikh Zayed Post-Graduate Medical Institute