Acute Coronary SyndromePhase 1/2A-ACS-PKNCT04715269
Role of Alprazolam in the Management of Acute Coronary Syndrome
A Phase 1/2 study testing Alprazolam in people with Acute Coronary Syndrome and Myocardial Infarction, run by Sohaib Ashraf at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Acute Coronary Syndrome, Myocardial Infarction, ST Elevation Myocardial Infarction
- What is being tested?
- Alprazolam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 sitePakistan
- Study dates
- 25 Dec 2020to 20 Feb 2022
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Systolic BP>100mm Hg Age between 18-80 years Sinus Rhythm
Who cannot join
- 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)
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Shaikh Zayed Post-Graduate Medical Institute
Lahore, 54600
Qazi Abdul Saboor, MBBS, +923004127598, drsaboor04@gmail.com
Sohaib Ashraf, MBBS, 8573167995, sohaib-ashraf@outlook.com
About this study
Official title: Effect of Alprazolam on Heart Rate and Acute Inflammatory Marker in Acute Coronary Syndrome Patients
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).
Read the 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.
- Conditions
- Acute Coronary Syndrome, Myocardial Infarction, ST Elevation Myocardial Infarction, Heart Diseases, Anxiety
- Being tested
- Alprazolam, Placebo
- Keywords
- Cardiology, Acute Coronary Syndrome, Heart Rate, Alprazolam, Anxiolytic
- Medical subject headings
- Acute Coronary Syndrome, Myocardial Infarction, ST Elevation Myocardial Infarction, Heart Diseases, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlprazolamDrug
Alprazolam 0.5 mg will be given when the patient with acute coronary syndrome would present to the emergency
PlaceboOther
Empty capsule
| Study group | Role | What they receive |
|---|---|---|
| Alprazolam Arm | Experimental | 0.5mg Alprazolam will be given to the patient at the time of presentation Receives: Drug: Alprazolam |
| Placebo Arm | Placebo comparator | The empty capsule will be given to the patient at the time of presentation Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate
Heart Rate reduction
Measured: upto 72 hours
Duration of Hospital stay
Number of days
Measured: upto 14 days
Mortality
death of patients
Measured: upto 14 days
recurrent symptomatic ischemia
episodes of angina
Measured: 72 hours
erythrocyte sedimentation rate (ESR)
Acute phase reactants
Measured: upto 72 hours
C-reactive protein (CRP)
Acute phase reactants
Measured: upto 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start25 Dec 2020
- Primary completion15 Nov 2021 (estimated)
- Study completion20 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This randomized, close label, placebo-controlled study with superiority framework as add-on therapy in ACS patients
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohaib Ashraf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sohaib Ashraf, Sheikh Zayed Federal Postgraduate Medical Institute
- Investigators
- Qazi Abdul Saboor, MBBS, Study chair, Shaikh Zayed Post-Graduate Medical InstituteSohaib Ashraf, MBBS, Principal investigator, Shaikh Zayed Post-Graduate Medical Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04715269
- Sponsor's protocol ID
- SZMC/IRB/0022
- Acronym
- A-ACS-PK
- Status last verified
- Jan 2021
- First submitted
- 15 Jan 2021
- Last updated
- 20 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Alprazolam on Heart Rate and Acute Inflammatory Marker in Acute Coronary Syndrome Patients
- ClinicalTrials.gov ID
- NCT04715269
- Acronym / sponsor ID
- A-ACS-PK / SZMC/IRB/0022
- Conditions
- Acute Coronary Syndrome, Myocardial Infarction, ST Elevation Myocardial Infarction, Heart Diseases, Anxiety
- Keywords
- Cardiology, Acute Coronary Syndrome, Heart Rate, Alprazolam, Anxiolytic
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Sohaib AshrafUniversity, hospital or other
- Study start
- 25 Dec 2020 (actual)
- Primary completion
- 15 Nov 2021 (estimated)
- Study completion
- 20 Feb 2022 (estimated)
- First posted
- 20 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This randomized, close label, placebo-controlled study with superiority framework as add-on therapy in ACS patients
| Arm | Type | Receives |
|---|---|---|
| Alprazolam Arm | Experimental | Drug: Alprazolam0.5mg Alprazolam will be given to the patient at the time of presentation |
| Placebo Arm | Placebo comparator | Other: PlaceboThe empty capsule will be given to the patient at the time of presentation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Systolic BP>100mm Hg Age between 18-80 years Sinus Rhythm
Key exclusion criteria (12 listed)
- Cardiogenic Shock / Hypotension
- Known Asthma/COPD
- Bradycardia (HR < 60)
- Already on Beta blockers/ Anxiolytics
- Sick sinus syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlprazolamAlprazolam 0.5 mg will be given when the patient with acute coronary syndrome would present to the emergency | Drug | Alprazolam Arm |
| PlaceboEmpty capsule | Other | Placebo Arm |
Primary outcome
Heart Rate
Time frame: upto 72 hours
Heart Rate reduction
Duration of Hospital stay
Time frame: upto 14 days
Number of days
Mortality
Time frame: upto 14 days
death of patients
recurrent symptomatic ischemia
Time frame: 72 hours
episodes of angina
erythrocyte sedimentation rate (ESR)
Time frame: upto 72 hours
Acute phase reactants
C-reactive protein (CRP)
Time frame: upto 72 hours
Acute phase reactants
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qazi Abdul Saboor, MBBS study chair
Shaikh Zayed Post-Graduate Medical Institute
Sohaib Ashraf, MBBS principal investigator
Shaikh Zayed Post-Graduate Medical Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Alprazolam in people with Acute Coronary Syndrome and Myocardial Infarction, run by Sohaib Ashraf at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sohaib Ashraf, MBBS (+18573167995, sohaib@skzmdc.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate (time frame: upto 72 hours). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2021.