Acute Ischemic StrokePhase 1/2NCT05415150
Platelet Function in Patients With Ischemic Stroke Treated With Anti-thrombotic or Thrombolytic
A Phase 1/2 study testing Thrombolytic Agent in people with Acute Ischemic Stroke, run by Baylor College of Medicine at 1 site in United States.
Trial summary
Acute stroke afflicts nearly 700,000 patients in the US and is the number 3 cause of death. Only 2-9% of this large number is treated with t-PA if they arrive within 4.5 hours. An equally small percentage of patients with large vessel occlusion undergo thrombectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Thrombolytic Agent
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2022to 31 May 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects are 18 years or older
- Anterior Circulation stroke within the last six hours
- Posterior Circulation stroke within the last 12 hours
Who cannot join
- Initial CT of the head suggests stroke like symptoms are not due to an ischemic stroke but a result of hemorrhage or tumor
- Platelet count below 100,000
- PTT greater than 75 while on treatment with heparin
- INR greater than 2.5 while on treatment with warfarin
- ACT>250
- Have clinical signs and symptoms of liver failure or elevations in AST, and ALT > 3 times the normal values.
Show all 9Show fewer
- Creatinine greater than 2
- Treatment team considers the patient to be at increased risk of intra-cerebral hemorrhages or systemic bleeding
- Pre-morbid modified Rankin score >2 suggesting a functionally dependent patient.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Michael E. DeBakey VA Medical Center
Houston, Texas, 77030
Pitchaiah Mandava, MD PhD MSEE
About this study
Official title: MEASUREMENT OF MARKERS OF PLATELET AGGREGATION AND INFLAMMATION IN ISCHEMIC STROKE SUBJECTS AFTER FIBRINOLYTIC/ANTI-THROMBOTIC USE. A PILOT STUDY.
Acute stroke afflicts nearly 700,000 patients in the US and is the number 3 cause of death. Only 2-9% of this large number is treated with t-PA if they arrive within 4.5 hours. An equally small percentage of patients with large vessel occlusion undergo thrombectomy.
The thrombectomy patients may or may not receive t-PA. Some of these patients rarely receive intravenous GPIIB/IIIa inhibitors. Many lines of evidence suggest that GP IIb/IIIa inhibitors, a class of FDA approved potent platelet inhibitors that have been used extensively along with heparin for acute coronary syndromes (heart attacks) and unstable angina (chest pain), may be safe enough to give in these circumstances.
Read the detailed description
In the past we used 30% lower dose of abciximab compared to the cardiac trials and the discontinued ABESTT stroke trial. There were no symptomatic intracranial hemorrhages or thromboyctopenia in our study. Based on the safety and efficacy results (Mandava et al, Translational Stroke Research 2010), we continued its use until manufacture of this agent was stopped.
There is another compound eptifibatide (Integrilin), that is also a GP IIb/IIIa which is in use in acute coronary syndromes. Eptifibatide has been used by cardiologists since 1998. Reduced doses have been studied along with intravenous rt-PA in stroke patients [Pancioli et al 2008 and 2013].
We are proposing even smaller dose compared to Pancioli et al 2008 and 2013. The reduced dose proposed here is less than 1/10th (<10%) cardiac dose. For an 80 kg patient the cardiac dose is 244 mg (14 mg bolus followed by an infusion of 230 mg over 24 hours). The reduced dose proposed here for stroke for an 80 kilogram patient is 10 mg bolus followed by an infusion of 10 mg over 24 hours. For patients weighing more than 80 kg the maximum bolus and infusion doses will remain 10 mg each. The cardiac dose does not specify a maximum weight.
If patients are eligible to receive alteplase as standard of care, patients will be offered alteplase.
Platelet aggregation has many poorly understood complex roles in ischemic stroke. We are planning on drawing three tubes of blood in addition before and after treatment. The tubes of blood will be collected at the bedside after consent and will be coordinated with the regularly scheduled blood draw that a patient undergoes at presentation to the emergency room. The three tubes of blood will be obtained and tests available in the laboratory will be performed. The three tests are Platelet Function Assay (PFA), Verify-Now (Aspirin) and Verify-Now(Plavix).
- Conditions
- Acute Ischemic Stroke
- Being tested
- Thrombolytic Agent
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thrombolytic AgentDrug
Also called eptifibatide, thrombectomy
Subjects may receive one or more of the treatment options
| Study group | Role | What they receive |
|---|---|---|
| Measurement of Platelet function | Experimental | Patients with ischemic stroke may be given alteplase or other thrombolytic. Additionally, patients may be given IV platelet inhibitors and subjected to thrombectomy. Platelet functions are measured after intervention. Receives: Drug: Thrombolytic Agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ninety day functional outcomes
Modified Rankin Score
Measured: Ninety days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2022
- Study start18 Feb 2022
- Primary completion1 Aug 2023 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pitchaiah Mandava, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05415150
- Sponsor's protocol ID
- H-31232
- Status last verified
- Jun 2022
- First submitted
- 8 Jun 2022
- Last updated
- 10 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MEASUREMENT OF MARKERS OF PLATELET AGGREGATION AND INFLAMMATION IN ISCHEMIC STROKE SUBJECTS AFTER FIBRINOLYTIC/ANTI-THROMBOTIC USE. A PILOT STUDY.
- ClinicalTrials.gov ID
- NCT05415150
- Acronym / sponsor ID
- H-31232
- Conditions
- Acute Ischemic Stroke
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- 18 Feb 2022 (actual)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 10 Jun 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.
Acute stroke afflicts nearly 700,000 patients in the US and is the number 3 cause of death. Only 2-9% of this large number is treated with t-PA if they arrive within 4.5 hours. An equally small percentage of patients with large vessel occlusion undergo thrombectomy.
The thrombectomy patients may or may not receive t-PA. Some of these patients rarely receive intravenous GPIIB/IIIa inhibitors. Many lines of evidence suggest that GP IIb/IIIa inhibitors, a class of FDA approved potent platelet inhibitors that have been used extensively along with heparin for acute coronary syndromes (heart attacks) and unstable angina (chest pain), may be safe enough to give in these circumstances.
Detailed description
In the past we used 30% lower dose of abciximab compared to the cardiac trials and the discontinued ABESTT stroke trial. There were no symptomatic intracranial hemorrhages or thromboyctopenia in our study. Based on the safety and efficacy results (Mandava et al, Translational Stroke Research 2010), we continued its use until manufacture of this agent was stopped.
There is another compound eptifibatide (Integrilin), that is also a GP IIb/IIIa which is in use in acute coronary syndromes. Eptifibatide has been used by cardiologists since 1998. Reduced doses have been studied along with intravenous rt-PA in stroke patients [Pancioli et al 2008 and 2013].
We are proposing even smaller dose compared to Pancioli et al 2008 and 2013. The reduced dose proposed here is less than 1/10th (<10%) cardiac dose. For an 80 kg patient the cardiac dose is 244 mg (14 mg bolus followed by an infusion of 230 mg over 24 hours). The reduced dose proposed here for stroke for an 80 kilogram patient is 10 mg bolus followed by an infusion of 10 mg over 24 hours. For patients weighing more than 80 kg the maximum bolus and infusion doses will remain 10 mg each. The cardiac dose does not specify a maximum weight.
If patients are eligible to receive alteplase as standard of care, patients will be offered alteplase.
Platelet aggregation has many poorly understood complex roles in ischemic stroke. We are planning on drawing three tubes of blood in addition before and after treatment. The tubes of blood will be collected at the bedside after consent and will be coordinated with the regularly scheduled blood draw that a patient undergoes at presentation to the emergency room. The three tubes of blood will be obtained and tests available in the laboratory will be performed. The three tests are Platelet Function Assay (PFA), Verify-Now (Aspirin) and Verify-Now(Plavix).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Measurement of Platelet function | Experimental | Drug: Thrombolytic AgentPatients with ischemic stroke may be given alteplase or other thrombolytic. Additionally, patients may be given IV platelet inhibitors and subjected to thrombectomy. Platelet functions are measured after intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects are 18 years or older
- Anterior Circulation stroke within the last six hours
- Posterior Circulation stroke within the last 12 hours
Key exclusion criteria (9 listed)
- Initial CT of the head suggests stroke like symptoms are not due to an ischemic stroke but a result of hemorrhage or tumor
- Platelet count below 100,000
- PTT greater than 75 while on treatment with heparin
- INR greater than 2.5 while on treatment with warfarin
- ACT>250
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 |
|---|---|---|
| Thrombolytic AgentAlso: eptifibatide, thrombectomySubjects may receive one or more of the treatment options | Drug | Measurement of Platelet function |
Primary outcome
Ninety day functional outcomes
Time frame: Ninety days
Modified Rankin Score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2022.
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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.
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 Thrombolytic Agent in people with Acute Ischemic Stroke, run by Baylor College of Medicine at 1 site in United States.
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 3 inclusion and 9 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 10 Jun 2022. 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 United States. 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 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 Pitchaiah Mandava, MD PhD MSEE (713 794 8906, pmandava@bcm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ninety day functional outcomes (time frame: Ninety days). 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 10 Jun 2022.