Recruiting
Phase 1
Phase 2

Anti-thrombotic & Thrombolytic

Sponsor:

Baylor College of Medicine

Code:

NCT05415150

Conditions

Acute Ischemic Stroke

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Thrombolytic Agent

Study Details

Brief 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.

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.

Conditions

Acute Ischemic Stroke

Study ID

NCT05415150

Start date

Feb 18, 2022

Status verified date

Jun, 2022

Completion date

May 31, 2024

Anticipated

Primary completion date

Aug 1, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Subjects are 18 years or older
2. Anterior Circulation stroke within the last six hours
3. Posterior Circulation stroke within the last 12 hours

Exclusion Criteria:

1. Initial CT of the head suggests stroke like symptoms are not due to an ischemic stroke but a result of hemorrhage or tumor
2. Platelet count below 100,000
3. PTT greater than 75 while on treatment with heparin
4. INR greater than 2.5 while on treatment with warfarin
5. ACT>250
6. Have clinical signs and symptoms of liver failure or elevations in AST, and ALT > 3 times the normal values.
7. Creatinine greater than 2
8. Treatment team considers the patient to be at increased risk of intra-cerebral hemorrhages or systemic bleeding
9. Pre-morbid modified Rankin score >2 suggesting a functionally dependent patient.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Measurement of Platelet function

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.

Interventions

Thrombolytic Agent

Subjects may receive one or more of the treatment options

Primary outcome measure

  • Ninety day functional outcomes [ Time Frame: Ninety days ]

Central Contacts and Locations

Central contacts

Pitchaiah Mandava, MD PhD MSEE

713 794 8906pmandava@bcm.edu

Locations

Michael E. DeBakey VA Medical Center

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

Baylor College of Medicine

Last update posted

Jun 10, 2022

Last verified

Jun, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Baylor College of Medicine on 2022-06-10.