Clinical trial NCT04715269: Role of Alprazolam in the Management of Acute Coronary Syndrome
Official title: Effect of Alprazolam on Heart Rate and Acute Inflammatory Marker in Acute Coronary Syndrome Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Acute Coronary Syndrome
Myocardial Infarction
ST Elevation Myocardial Infarction
Heart Diseases
Anxiety
Keywords: Cardiology
Acute Coronary Syndrome
Heart Rate
Alprazolam
Anxiolytic
Lead sponsor: Sheikh Zayed Federal Postgraduate Medical Institute
Sponsor class: OTHER
First posted: 2021-01-20
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This randomized, close label, placebo-controlled study with superiority framework as add-on therapy in ACS patients
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Heart Rate
timeFrame: upto 72 hours
measure: Duration of Hospital stay
timeFrame: upto 14 days
measure: Mortality
timeFrame: upto 14 days
measure: recurrent symptomatic ischemia
timeFrame: 72 hours
measure: erythrocyte sedimentation rate (ESR)
timeFrame: upto 72 hours
measure: C-reactive protein (CRP)
timeFrame: upto 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Shaikh Zayed Post-Graduate Medical Institute
Study officials:
affiliation: Shaikh Zayed Post-Graduate Medical Institute
name: Qazi Abdul Saboor, MBBS
role: STUDY_CHAIR
affiliation: Shaikh Zayed Post-Graduate Medical Institute
name: Sohaib Ashraf, MBBS
role: PRINCIPAL_INVESTIGATOR
References: