NCT04715269

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 25, 2020

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 20, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2022

Completed
Last Updated

January 20, 2021

Status Verified

January 1, 2021

Enrollment Period

11 months

First QC Date

January 15, 2021

Last Update Submit

January 19, 2021

Conditions

Acute Coronary SyndromeMyocardial InfarctionST Elevation Myocardial InfarctionHeart DiseasesAnxiety

Keywords

CardiologyAcute Coronary SyndromeHeart RateAlprazolamAnxiolytic

Outcome Measures

Primary Outcomes (6)

  • Heart Rate

    Heart Rate reduction

    upto 72 hours

  • Duration of Hospital stay

    Number of days

    upto 14 days

  • Mortality

    death of patients

    upto 14 days

  • recurrent symptomatic ischemia

    episodes of angina

    72 hours

  • erythrocyte sedimentation rate (ESR)

    Acute phase reactants

    upto 72 hours

  • C-reactive protein (CRP)

    Acute phase reactants

    upto 72 hours

Study Arms (2)

Alprazolam Arm

EXPERIMENTAL

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

Drug: Alprazolam

Placebo Arm

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

AlprazolamDRUG

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

Alprazolam Arm
PlaceboOTHER

Empty capsule

Placebo Arm

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Systolic BP\>100mm Hg Age between 18-80 years Sinus Rhythm

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaikh Zayed Post-Graduate Medical Institute

Lahore, 54600, Pakistan

RECRUITING

MeSH Terms

Conditions

Acute Coronary SyndromeMyocardial InfarctionST Elevation Myocardial InfarctionHeart DiseasesAnxiety Disorders

Interventions

Alprazolam

Condition Hierarchy (Ancestors)

Myocardial IschemiaCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisMental Disorders

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Qazi Abdul Saboor, MBBS

    Shaikh Zayed Post-Graduate Medical Institute

    STUDY CHAIR

  • Sohaib Ashraf, MBBS

    Shaikh Zayed Post-Graduate Medical Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sohaib Ashraf, MBBS

CONTACT

+18573167995sohaib@skzmdc.edu.pk

Ahmad Imran, MBBS

CONTACT

+923334474523ahmad.imran@skzmdc.edu.pk

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Masking will be done for all participants
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This randomized, close label, placebo-controlled study with superiority framework as add-on therapy in ACS patients
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Registrar Cardiology

Study Record Dates

First Submitted

January 15, 2021

First Posted

January 20, 2021

Study Start

December 25, 2020

Primary Completion

November 15, 2021

Study Completion

February 20, 2022

Last Updated

January 20, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)