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

Primary Purpose

Acute Coronary Syndrome, Myocardial Infarction, ST Elevation Myocardial Infarction

Status
Unknown status
Phase
Phase 1
Locations
Pakistan
Study Type
Interventional
Intervention
Alprazolam
Placebo
Sponsored by
Sohaib Ashraf
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring Cardiology, Acute Coronary Syndrome, Heart Rate, Alprazolam, Anxiolytic

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Shaikh Zayed Post-Graduate Medical InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Alprazolam Arm

Placebo Arm

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 15, 2021
Last Updated
January 19, 2021
Sponsor
Sohaib Ashraf
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1. Study Identification

Unique Protocol Identification Number
NCT04715269
Brief Title
Role of Alprazolam in the Management of Acute Coronary Syndrome
Acronym
A-ACS-PK
Official Title
Effect of Alprazolam on Heart Rate and Acute Inflammatory Marker in Acute Coronary Syndrome Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 25, 2020 (Actual)
Primary Completion Date
November 15, 2021 (Anticipated)
Study Completion Date
February 20, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sohaib Ashraf

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome, Myocardial Infarction, ST Elevation Myocardial Infarction, Heart Diseases, Anxiety
Keywords
Cardiology, Acute Coronary Syndrome, Heart Rate, Alprazolam, Anxiolytic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
This randomized, close label, placebo-controlled study with superiority framework as add-on therapy in ACS patients
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Masking will be done for all participants
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Alprazolam Arm
Arm Type
Experimental
Arm Description
0.5mg Alprazolam will be given to the patient at the time of presentation
Arm Title
Placebo Arm
Arm Type
Placebo Comparator
Arm Description
The empty capsule will be given to the patient at the time of presentation
Intervention Type
Drug
Intervention Name(s)
Alprazolam
Intervention Description
Alprazolam 0.5 mg will be given when the patient with acute coronary syndrome would present to the emergency
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Empty capsule
Primary Outcome Measure Information:
Title
Heart Rate
Description
Heart Rate reduction
Time Frame
upto 72 hours
Title
Duration of Hospital stay
Description
Number of days
Time Frame
upto 14 days
Title
Mortality
Description
death of patients
Time Frame
upto 14 days
Title
recurrent symptomatic ischemia
Description
episodes of angina
Time Frame
72 hours
Title
erythrocyte sedimentation rate (ESR)
Description
Acute phase reactants
Time Frame
upto 72 hours
Title
C-reactive protein (CRP)
Description
Acute phase reactants
Time Frame
upto 72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sohaib Ashraf, MBBS
Phone
+18573167995
Email
sohaib@skzmdc.edu.pk
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmad Imran, MBBS
Phone
+923334474523
Email
ahmad.imran@skzmdc.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qazi Abdul Saboor, MBBS
Organizational Affiliation
Shaikh Zayed Post-Graduate Medical Institute
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sohaib Ashraf, MBBS
Organizational Affiliation
Shaikh Zayed Post-Graduate Medical Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shaikh Zayed Post-Graduate Medical Institute
City
Lahore
ZIP/Postal Code
54600
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qazi Abdul Saboor, MBBS
Phone
+923004127598
Email
drsaboor04@gmail.com
First Name & Middle Initial & Last Name & Degree
Sohaib Ashraf, MBBS
Phone
8573167995
Email
sohaib-ashraf@outlook.com
First Name & Middle Initial & Last Name & Degree
Sohaib Ashraf, MBBS
First Name & Middle Initial & Last Name & Degree
Usama Farooq, MBBS
First Name & Middle Initial & Last Name & Degree
Ayesha Khaqan, MBBS
First Name & Middle Initial & Last Name & Degree
Abubakar Hilal, MBBS
First Name & Middle Initial & Last Name & Degree
Arz Muhammad, MBBS

12. IPD Sharing Statement

Plan to Share IPD
No

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Role of Alprazolam in the Management of Acute Coronary Syndrome

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