Coronary ThrombosisPhase 2NCT05647018
In-hospital Clinical Outcome of Deferred Stenting Versus Immediate Stenting in the Management of Acute STEMI Presenting With High Thrombus Burden.
A Phase 2 study testing Primary Percutaneous coronary angiography in people with Coronary Thrombosis, run by Assiut University.
Trial summary
To compare the in hospital clinical outcomes in terms of efficacy and safety of deferred stenting versus non-deferred stenting in STEMI patients with high thrombus burden undergoing primary percutaneous intervention. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Thrombosis
- What is being tested?
- Primary Percutaneous coronary angiography
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2022to 30 Jun 2024
- Phase
- Phase 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- TIMI 2-3 flow in the infarct related artery (IRA) with high thrombus burden at initial angiography.
- TIMI 2-3 in the IRA with high thrombus burden after MIMI.
Who cannot join
- TIMI 0-1 flow in the IRA after MIMI.
- TIMI 2-3 in the IRA with low thrombus burden.
- Contraindication or hypersensitivity to Tirofiban
- High bleeding risk calculated using the CRUSADE score >50.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: In-hospital Clinical Outcome of Deferred Stenting Versus Immediate Stenting in the Management of Acute STEMI Presenting With High Thrombus Burden: A Randomized Control Study
To compare the in hospital clinical outcomes in terms of efficacy and safety of deferred stenting versus non-deferred stenting in STEMI patients with high thrombus burden undergoing primary percutaneous intervention.
Read the detailed description
Angiographically, intracoronary thrombus is defined as the presence of a filling defect with reduced contrast density or haziness. Angiographic evidence of thrombus can be seen in 91.6% of patients who present with STEMI(1). Large intracoronary thrombus has an incidence of 16.4% of patients with acute coronary syndrome (ACS).
Thrombus encountered in the setting of ACS has been correlated with acute complications during percutaneous coronary interventions including: 3 times higher MACE - ischemic complications, lower procedural success, higher distal embolization leading to slow/no flow, high mortality, ST elevation and longer hospital stays.
High thrombus burden can be defined using Yip's criteria:
- Large infarct-related artery (visually estimated reference vessel diameter ≥ 4 mm)
- Angiographic thrombus with the greatest linear dimension > 3 times the reference vessel diameter;
- "Cutoff pattern" (lesion morphology with an abrupt cutoff without taper before the occlusion);
- Accumulated thrombus (> 5 mm of linear dimension) proximal to the occlusion;
- Floating thrombus proximal to the occlusion;
- Persistent dye stasis distal to the obstruction. IF more than two criteria indicate the presence of very high thrombus burden.
PCI Strategies introduced in HIGH thrombus BURDEN include incorporation of both pharmacological and mechanical thrombus removal.
Immediate stenting of the culprit coronary artery may lead to high chances of the slow-flow/no-reflow phenomenon that leads to periprocedural MI and adverse cardiovascular events. Current studies show that routine deferred stenting has not been found beneficial except when careful patient selection is done where deferral may reduce the final infarct size.
Glycoprotein IIa/IIIb inhibitors have been used in such cases. Current guidelines recommend GPIIa/IIb as bailout therapy following PCI when massive thrombus is found: Class IIa. (6) The rationale in using intracoronary GPIIa/IIIb is that it can be more effective, faster and safer in terms of bleeding.
Deferred stenting is a method of dealing with thigh thrombus burden in STEMI patients. This means to wait 24-48 hour and delay stenting. During this time gap, patient receives intravenous tirofiban. This may be beneficial as the thrombus burden will reduce, minimizing the occurrence of the slow-flow/no-reflow phenomenon.
During coronary angiography the epicardial perfusion can be demonstrated using the TIMI grade flow where:
- TIMI 0 flow (no perfusion) complete blockage - absence of any antegrade flow (forward flow) beyond a coronary occlusion.
- TIMI 1 flow (penetration without perfusion) is faint antegrade coronary flow beyond the occlusion, with incomplete filling of the distal coronary bed.
- TIMI 2 flow (partial reperfusion) is delayed or sluggish antegrade flow with complete filling of the distal territory.
- TIMI 3 is normal flow which fills the distal coronary bed completely. (7) During Primary PCI, If TIMI 0-1 flow is encountered a technique called minimally invasive mechanical intervention (MIMI) can be employed to restore flow. This MIMI entails the use of a guidewire, an undersized balloon or thrombus aspiration to establish distal coronary flow.
- Conditions
- Coronary Thrombosis
- Being tested
- Primary Percutaneous coronary angiography
- Medical subject headings
- Coronary Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary Percutaneous coronary angiographyProcedure or surgery
Also called Minimally invasive mechanical intervention
Percutaneous coronary intervention (PCI) refers to a family of minimally invasive procedures used to open clogged coronary arteries in patients presenting with myocardial infarction, through which installment of stents or intracoronary injection of drugs can take place.
| Study group | Role | What they receive |
|---|---|---|
| Deferred stenting in STEMI patients with high thrombus burden undergoing primary PCI | Active comparator | Not described Receives: Procedure: Primary Percutaneous coronary angiography |
| Non-deferred stenting in STEMI patients with high thrombus burden undergoing primary PCI | Active comparator | Not described Receives: Procedure: Primary Percutaneous coronary angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of the method used in terms of TIMI flow
By TIMI III flow finding
Measured: During in hospital stay up to 36 hours
Effectiveness of the method used in regards to ECG.
ECG: ST segment resolution immediately after PCI and 90 minutes after PCI
Measured: During in hospital stay up to 36 hours
Effectiveness of the method used in regards to development of heart failure.
Development of acute heart failure after PCI during hospital admission.
Measured: During in hospital stay up to 36 hours
Effectiveness of the method used in regards to mortality.
Death during hospital stay post-PCI.
Measured: During in hospital stay up to 36 hours
Safety of the method used in regards to bleeding.
Bleeding events will be noted and classified according to BARC (Bleeding Academic Research Consortium) bleeding score during hospital stay post-PCI
Measured: During in hospital stay up to 36 hours
Safety of the method used in regard to development of arrhythmia.
Development of arrhythmia post-PCI will be noted and the type of arrhythmia will be identified.
Measured: During in hospital stay up to 36 hours
Secondary outcomes (2)
Follow up post-PCI by trans-thoracic Echo
To estimate the ejection fraction on discharge.
Measured: During in hospital stay up to 36 hours
Follow up post-PCI in regards to MACE (Major adverse cardiac events)
The development of MACE: Death, myocardial infarction, hospitalization due to heart failure, recurrent PCI or CABG.
Measured: 3 and 6 months after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start1 Dec 2022 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Coronary ThrombosisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yomna Mahmoud Shokry Abdelrehim, Assiut University
- Investigators
- Mohammed Abdelghany, Prof, Study director, Assiut UniversityAyman Khairy, Prof, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05647018
- Sponsor's protocol ID
- PPCI in STEMI
- Status last verified
- Dec 2022
- First submitted
- 19 Nov 2022
- Last updated
- 12 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sianos G, Papafaklis MI, Daemen J, Vaina S, van Mieghem CA, van Domburg RT, Michalis LK, Serruys PW. Angiographic stent thrombosis after routine use of drug-eluting stents in ST-segment elevation myocardial infarction: the importance of thrombus burden. J Am Coll Cardiol. 2007 Aug 14;50(7):573-83. doi: 10.1016/j.jacc.2007.04.059. Epub 2007 Jul 30.
PubMed 17692740Miranda-Guardiola F, Rossi A, Serra A, Garcia B, Rumoroso JR, Iniguez A, Vaquerizo B, Triano JL, Sierra G, Bruguera J; Spanish AMIcath Registry. Angiographic quantification of thrombus in ST-elevation acute myocardial infarction presenting with an occluded infarct-related artery and its relationship with results of percutaneous intervention. J Interv Cardiol. 2009 Jun;22(3):207-15. doi: 10.1111/j.1540-8183.2009.00464.x. Epub 2009 Apr 14.
PubMed 19490354Kumar V, Sharma AK, Kumar T, Nath RK. Large intracoronary thrombus and its management during primary PCI. Indian Heart J. 2020 Nov-Dec;72(6):508-516. doi: 10.1016/j.ihj.2020.11.009. Epub 2020 Nov 19.
PubMed 33357638Yip HK, Chen MC, Chang HW, Hang CL, Hsieh YK, Fang CY, Wu CJ. Angiographic morphologic features of infarct-related arteries and timely reperfusion in acute myocardial infarction: predictors of slow-flow and no-reflow phenomenon. Chest. 2002 Oct;122(4):1322-32. doi: 10.1378/chest.122.4.1322.
PubMed 12377860Pradhan A, Bhandari M, Vishwakarma P, Sethi R. Deferred Stenting for Heavy Thrombus Burden During Percutaneous Coronary Intervention for ST-Elevation MI. Eur Cardiol. 2021 Mar 30;16:e08. doi: 10.15420/ecr.2020.31. eCollection 2021 Feb.
PubMed 33897834Ibanez B, James S, Agewall S, Antunes MJ, Bucciarelli-Ducci C, Bueno H, Caforio ALP, Crea F, Goudevenos JA, Halvorsen S, Hindricks G, Kastrati A, Lenzen MJ, Prescott E, Roffi M, Valgimigli M, Varenhorst C, Vranckx P, Widimsky P; ESC Scientific Document Group. 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: The Task Force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2018 Jan 7;39(2):119-177. doi: 10.1093/eurheartj/ehx393. No abstract available.
PubMed 28886621Chesebro JH, Knatterud G, Roberts R, Borer J, Cohen LS, Dalen J, Dodge HT, Francis CK, Hillis D, Ludbrook P, et al. Thrombolysis in Myocardial Infarction (TIMI) Trial, Phase I: A comparison between intravenous tissue plasminogen activator and intravenous streptokinase. Clinical findings through hospital discharge. Circulation. 1987 Jul;76(1):142-54. doi: 10.1161/01.cir.76.1.142.
PubMed 3109764Vranckx P, White HD, Huang Z, Mahaffey KW, Armstrong PW, Van de Werf F, Moliterno DJ, Wallentin L, Held C, Aylward PE, Cornel JH, Bode C, Huber K, Nicolau JC, Ruzyllo W, Harrington RA, Tricoci P. Validation of BARC Bleeding Criteria in Patients With Acute Coronary Syndromes: The TRACER Trial. J Am Coll Cardiol. 2016 May 10;67(18):2135-2144. doi: 10.1016/j.jacc.2016.02.056.
PubMed 27151345
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-hospital Clinical Outcome of Deferred Stenting Versus Immediate Stenting in the Management of Acute STEMI Presenting With High Thrombus Burden: A Randomized Control Study
- ClinicalTrials.gov ID
- NCT05647018
- Acronym / sponsor ID
- PPCI in STEMI
- Conditions
- Coronary Thrombosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 12 Dec 2022 (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.
To compare the in hospital clinical outcomes in terms of efficacy and safety of deferred stenting versus non-deferred stenting in STEMI patients with high thrombus burden undergoing primary percutaneous intervention.
Detailed description
Angiographically, intracoronary thrombus is defined as the presence of a filling defect with reduced contrast density or haziness. Angiographic evidence of thrombus can be seen in 91.6% of patients who present with STEMI(1). Large intracoronary thrombus has an incidence of 16.4% of patients with acute coronary syndrome (ACS).
Thrombus encountered in the setting of ACS has been correlated with acute complications during percutaneous coronary interventions including: 3 times higher MACE - ischemic complications, lower procedural success, higher distal embolization leading to slow/no flow, high mortality, ST elevation and longer hospital stays.
High thrombus burden can be defined using Yip's criteria:
- Large infarct-related artery (visually estimated reference vessel diameter ≥ 4 mm)
- Angiographic thrombus with the greatest linear dimension > 3 times the reference vessel diameter;
- "Cutoff pattern" (lesion morphology with an abrupt cutoff without taper before the occlusion);
- Accumulated thrombus (> 5 mm of linear dimension) proximal to the occlusion;
- Floating thrombus proximal to the occlusion;
- Persistent dye stasis distal to the obstruction. IF more than two criteria indicate the presence of very high thrombus burden.
PCI Strategies introduced in HIGH thrombus BURDEN include incorporation of both pharmacological and mechanical thrombus removal.
Immediate stenting of the culprit coronary artery may lead to high chances of the slow-flow/no-reflow phenomenon that leads to periprocedural MI and adverse cardiovascular events. Current studies show that routine deferred stenting has not been found beneficial except when careful patient selection is done where deferral may reduce the final infarct size.
Glycoprotein IIa/IIIb inhibitors have been used in such cases. Current guidelines recommend GPIIa/IIb as bailout therapy following PCI when massive thrombus is found: Class IIa. (6) The rationale in using intracoronary GPIIa/IIIb is that it can be more effective, faster and safer in terms of bleeding.
Deferred stenting is a method of dealing with thigh thrombus burden in STEMI patients. This means to wait 24-48 hour and delay stenting. During this time gap, patient receives intravenous tirofiban. This may be beneficial as the thrombus burden will reduce, minimizing the occurrence of the slow-flow/no-reflow phenomenon.
During coronary angiography the epicardial perfusion can be demonstrated using the TIMI grade flow where:
- TIMI 0 flow (no perfusion) complete blockage - absence of any antegrade flow (forward flow) beyond a coronary occlusion.
- TIMI 1 flow (penetration without perfusion) is faint antegrade coronary flow beyond the occlusion, with incomplete filling of the distal coronary bed.
- TIMI 2 flow (partial reperfusion) is delayed or sluggish antegrade flow with complete filling of the distal territory.
- TIMI 3 is normal flow which fills the distal coronary bed completely. (7) During Primary PCI, If TIMI 0-1 flow is encountered a technique called minimally invasive mechanical intervention (MIMI) can be employed to restore flow. This MIMI entails the use of a guidewire, an undersized balloon or thrombus aspiration to establish distal coronary flow.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deferred stenting in STEMI patients with high thrombus burden undergoing primary PCI | Active comparator | Procedure: Primary Percutaneous coronary angiography |
| Non-deferred stenting in STEMI patients with high thrombus burden undergoing primary PCI | Active comparator | Procedure: Primary Percutaneous coronary angiography |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- TIMI 2-3 flow in the infarct related artery (IRA) with high thrombus burden at initial angiography.
- TIMI 2-3 in the IRA with high thrombus burden after MIMI.
Key exclusion criteria (4 listed)
- TIMI 0-1 flow in the IRA after MIMI.
- TIMI 2-3 in the IRA with low thrombus burden.
- Contraindication or hypersensitivity to Tirofiban
- High bleeding risk calculated using the CRUSADE score >50.
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 |
|---|---|---|
| Primary Percutaneous coronary angiographyAlso: Minimally invasive mechanical interventionPercutaneous coronary intervention (PCI) refers to a family of minimally invasive procedures used to open clogged coronary arteries in patients presenting with myocardial infarction, through which installment of stents or intracoronary injection of drugs can take place. | Procedure or surgery | Deferred stenting in STEMI patients with high thrombus burden undergoing primary PCI, Non-deferred stenting in STEMI patients with high thrombus burden undergoing primary PCI |
Primary outcome
Effectiveness of the method used in terms of TIMI flow
Time frame: During in hospital stay up to 36 hours
By TIMI III flow finding
Effectiveness of the method used in regards to ECG.
Time frame: During in hospital stay up to 36 hours
ECG: ST segment resolution immediately after PCI and 90 minutes after PCI
Effectiveness of the method used in regards to development of heart failure.
Time frame: During in hospital stay up to 36 hours
Development of acute heart failure after PCI during hospital admission.
Effectiveness of the method used in regards to mortality.
Time frame: During in hospital stay up to 36 hours
Death during hospital stay post-PCI.
Safety of the method used in regards to bleeding.
Time frame: During in hospital stay up to 36 hours
Bleeding events will be noted and classified according to BARC (Bleeding Academic Research Consortium) bleeding score during hospital stay post-PCI
Safety of the method used in regard to development of arrhythmia.
Time frame: During in hospital stay up to 36 hours
Development of arrhythmia post-PCI will be noted and the type of arrhythmia will be identified.
2 secondary outcomes
Follow up post-PCI by trans-thoracic Echo
Time frame: During in hospital stay up to 36 hours
Follow up post-PCI in regards to MACE (Major adverse cardiac events)
Time frame: 3 and 6 months after procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2022.
- Background: PubMed 17692740Sianos G, Papafaklis MI, Daemen J, Vaina S, van Mieghem CA, van Domburg RT, Michalis LK, Serruys PW. Angiographic stent thrombosis after routine use of drug-eluting stents in ST-segment elevation myocardial infarction: the importance of thrombus burden. J Am Coll Cardiol. 2007 Aug 14;50(7):573-83. doi: 10.1016/j.jacc.2007.04.059. Epub 2007 Jul 30.
- Background: PubMed 19490354Miranda-Guardiola F, Rossi A, Serra A, Garcia B, Rumoroso JR, Iniguez A, Vaquerizo B, Triano JL, Sierra G, Bruguera J; Spanish AMIcath Registry. Angiographic quantification of thrombus in ST-elevation acute myocardial infarction presenting with an occluded infarct-related artery and its relationship with results of percutaneous intervention. J Interv Cardiol. 2009 Jun;22(3):207-15. doi: 10.1111/j.1540-8183.2009.00464.x. Epub 2009 Apr 14.
- Background: PubMed 33357638Kumar V, Sharma AK, Kumar T, Nath RK. Large intracoronary thrombus and its management during primary PCI. Indian Heart J. 2020 Nov-Dec;72(6):508-516. doi: 10.1016/j.ihj.2020.11.009. Epub 2020 Nov 19.
- Background: PubMed 12377860Yip HK, Chen MC, Chang HW, Hang CL, Hsieh YK, Fang CY, Wu CJ. Angiographic morphologic features of infarct-related arteries and timely reperfusion in acute myocardial infarction: predictors of slow-flow and no-reflow phenomenon. Chest. 2002 Oct;122(4):1322-32. doi: 10.1378/chest.122.4.1322.
- Background: PubMed 33897834Pradhan A, Bhandari M, Vishwakarma P, Sethi R. Deferred Stenting for Heavy Thrombus Burden During Percutaneous Coronary Intervention for ST-Elevation MI. Eur Cardiol. 2021 Mar 30;16:e08. doi: 10.15420/ecr.2020.31. eCollection 2021 Feb.
- Background: PubMed 28886621Ibanez B, James S, Agewall S, Antunes MJ, Bucciarelli-Ducci C, Bueno H, Caforio ALP, Crea F, Goudevenos JA, Halvorsen S, Hindricks G, Kastrati A, Lenzen MJ, Prescott E, Roffi M, Valgimigli M, Varenhorst C, Vranckx P, Widimsky P; ESC Scientific Document Group. 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: The Task Force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2018 Jan 7;39(2):119-177. doi: 10.1093/eurheartj/ehx393. No abstract available.
- Background: PubMed 3109764Chesebro JH, Knatterud G, Roberts R, Borer J, Cohen LS, Dalen J, Dodge HT, Francis CK, Hillis D, Ludbrook P, et al. Thrombolysis in Myocardial Infarction (TIMI) Trial, Phase I: A comparison between intravenous tissue plasminogen activator and intravenous streptokinase. Clinical findings through hospital discharge. Circulation. 1987 Jul;76(1):142-54. doi: 10.1161/01.cir.76.1.142.
- Background: PubMed 27151345Vranckx P, White HD, Huang Z, Mahaffey KW, Armstrong PW, Van de Werf F, Moliterno DJ, Wallentin L, Held C, Aylward PE, Cornel JH, Bode C, Huber K, Nicolau JC, Ruzyllo W, Harrington RA, Tricoci P. Validation of BARC Bleeding Criteria in Patients With Acute Coronary Syndromes: The TRACER Trial. J Am Coll Cardiol. 2016 May 10;67(18):2135-2144. doi: 10.1016/j.jacc.2016.02.056.
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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.
Mohammed Abdelghany, Prof study director
Assiut University
Ayman Khairy, Prof study director
Assiut University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Primary Percutaneous coronary angiography in people with Coronary Thrombosis, run by Assiut University.
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 4 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 12 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
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 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 Yomna S Abdelrehim, Master student (01157090118 ext. +20, yomnashokry@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of the method used in terms of TIMI flow (time frame: During in hospital stay up to 36 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?
On the ClinicalTrials.gov record for NCT05647018, which also lists 8 linked publications.
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 12 Dec 2022.