Acute Coronary SyndromePhase 4NCT04699110
Adrenaline for the Treatment of No-Reflow in Normotensive Patients
A Phase 4 study testing Adrenaline and Adenosine in people with Acute Coronary Syndrome and No-Reflow Phenomenon, run by National Institute of Cardiovascular Diseases, Pakistan at 1 site in Pakistan.
Trial summary
No-reflow is defined as the lack of myocardial perfusion despite opening of the epicardial coronary vessels in the setting of percutaneous coronary intervention (PCI). It has been demonstrated that either impaired flow or the absence of flow is associated with an increased rate of mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome, No-Reflow Phenomenon, Normotensive
- What is being tested?
- Adrenaline and Adenosine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2021to 30 Apr 2021
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients with acute coronary syndrome who developed No-reflow during PCI.
- Patients with systolic blood pressure of > 100 mmHg.
Who cannot join
- Hypotensive patients
- Patients with Valvular or congenital heart disease.
- Patients with Atypical chest pain
- Patients with Cardiomyopathy
- Patients with Pericarditis
- Patients with Myocarditis
- Patients refused to give consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Intracoronary Adrenaline and Its Comparison With Intracoronary Adenosine in the Treatment of No-Reflow in Normotensive Patients With Acute Coronary Syndrome
No-reflow is defined as the lack of myocardial perfusion despite opening of the epicardial coronary vessels in the setting of percutaneous coronary intervention (PCI). It has been demonstrated that either impaired flow or the absence of flow is associated with an increased rate of mortality. Among available treatment options, intracoronary adenosine is widely used in clinical practice, moreover, adrenaline is a safe alternative for the cases where use of adenosine is limited due to presence of hypotension or bradycardia. Nonetheless, evidence from retrospective and observational studies suggest that intracoronary adrenaline is well tolerated and may exert encouraging effects in prompt recovery of flow in these patients. However, very limited data are available on efficacy of intracoronary (IC) adrenaline in normotensive patients. Therefore, this study is planned to study the hypothesis that; intracoronary adrenaline is safe and has significantly higher efficacy as compared to adenosine for the treatment of no-reflow in normotensive patients with acute coronary syndrome.
- Conditions
- Acute Coronary Syndrome, No-Reflow Phenomenon, Normotensive
- Being tested
- Adrenaline, Adenosine
- Medical subject headings
- Acute Coronary Syndrome, No-Reflow Phenomenon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdrenalineDrug
Treatment group will receive adrenaline (100 to 400 mcg) for the treatment of No-reflow
AdenosineDrug
Control group will receive adenosine (100 to 400 mcg)
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Patients receiving intracoronary adrenaline Receives: Drug: Adrenaline |
| Control group | Active comparator | Patients receiving intracoronary adenosine Receives: Drug: Adenosine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Thrombolysis in Myocardial Infarction (TIMI) flow grade
Measured: Immediately after administration of drug
Reduction in TIMI frame count
Measured: Immediately after administration of drug
Secondary outcomes (1)
The major adverse cardiovascular events
Measured: During hospital stay and at 30-day follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start1 Jan 2021
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Cardiovascular Diseases, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kamran Ahmed Khan, National Institute of Cardiovascular Diseases, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04699110
- Sponsor's protocol ID
- ERC-76/2020
- Status last verified
- May 2021
- First submitted
- 5 Jan 2021
- Last updated
- 21 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Khan KA, Qamar N, Saghir T, Sial JA, Kumar D, Kumar R, Qayyum D, Yasin U, Jalbani J, Karim M. Comparison of Intracoronary Epinephrine and Adenosine for No-Reflow in Normotensive Patients With Acute Coronary Syndrome (COAR Trial). Circ Cardiovasc Interv. 2022 Feb;15(2):e011408. doi: 10.1161/CIRCINTERVENTIONS.121.011408. Epub 2022 Jan 10.
PubMed 35000456
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Intracoronary Adrenaline and Its Comparison With Intracoronary Adenosine in the Treatment of No-Reflow in Normotensive Patients With Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT04699110
- Acronym / sponsor ID
- ERC-76/2020
- Conditions
- Acute Coronary Syndrome, No-Reflow Phenomenon, Normotensive
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- National Institute of Cardiovascular Diseases, PakistanUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 7 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.
No-reflow is defined as the lack of myocardial perfusion despite opening of the epicardial coronary vessels in the setting of percutaneous coronary intervention (PCI). It has been demonstrated that either impaired flow or the absence of flow is associated with an increased rate of mortality. Among available treatment options, intracoronary adenosine is widely used in clinical practice, moreover, adrenaline is a safe alternative for the cases where use of adenosine is limited due to presence of hypotension or bradycardia. Nonetheless, evidence from retrospective and observational studies suggest that intracoronary adrenaline is well tolerated and may exert encouraging effects in prompt recovery of flow in these patients. However, very limited data are available on efficacy of intracoronary (IC) adrenaline in normotensive patients. Therefore, this study is planned to study the hypothesis that; intracoronary adrenaline is safe and has significantly higher efficacy as compared to adenosine for the treatment of no-reflow in normotensive patients with acute coronary syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: AdrenalinePatients receiving intracoronary adrenaline |
| Control group | Active comparator | Drug: AdenosinePatients receiving intracoronary adenosine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients with acute coronary syndrome who developed No-reflow during PCI.
- Patients with systolic blood pressure of > 100 mmHg.
Key exclusion criteria (7 listed)
- Hypotensive patients
- Patients with Valvular or congenital heart disease.
- Patients with Atypical chest pain
- Patients with Cardiomyopathy
- Patients with Pericarditis
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 |
|---|---|---|
| AdrenalineTreatment group will receive adrenaline (100 to 400 mcg) for the treatment of No-reflow | Drug | Treatment group |
| AdenosineControl group will receive adenosine (100 to 400 mcg) | Drug | Control group |
Primary outcome
Improvement in Thrombolysis in Myocardial Infarction (TIMI) flow grade
Time frame: Immediately after administration of drug
Reduction in TIMI frame count
Time frame: Immediately after administration of drug
1 secondary outcome
The major adverse cardiovascular events
Time frame: During hospital stay and at 30-day follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2021.
- Derived from this study: PubMed 35000456Khan KA, Qamar N, Saghir T, Sial JA, Kumar D, Kumar R, Qayyum D, Yasin U, Jalbani J, Karim M. Comparison of Intracoronary Epinephrine and Adenosine for No-Reflow in Normotensive Patients With Acute Coronary Syndrome (COAR Trial). Circ Cardiovasc Interv. 2022 Feb;15(2):e011408. doi: 10.1161/CIRCINTERVENTIONS.121.011408. Epub 2022 Jan 10.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Adrenaline and Adenosine in people with Acute Coronary Syndrome and No-Reflow Phenomenon, run by National Institute of Cardiovascular Diseases, Pakistan 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 2 inclusion and 7 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: finished, as of the sponsor's last update on 21 May 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Thrombolysis in Myocardial Infarction (TIMI) flow grade (time frame: Immediately after administration of drug). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04699110, which also lists 1 linked publication.
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 21 May 2021.