Platelet Function in Patients With Ischemic Stroke Treated With Anti-thrombotic or Thrombolytic

NCT05415150 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: H-31232
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Ninety day functional outcomes

  Modified Rankin Score

  Ninety days

Study Arms (1)

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.

Drug: Thrombolytic Agent

Interventions

Thrombolytic Agent DRUG

Subjects may receive one or more of the treatment options

Also known as: eptifibatide, thrombectomy

Measurement of Platelet function

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects are 18 years or older
• Anterior Circulation stroke within the last six hours
• Posterior Circulation stroke within the last 12 hours

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Michael E. DeBakey VA Medical Center

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Fibrinolytic Agents; Eptifibatide; Thrombectomy

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Cardiovascular Agents; Therapeutic Uses; Hematologic Agents; Peptides, Cyclic; Peptides; Amino Acids, Peptides, and Proteins; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Pitchaiah Mandava, MD PhD MSEE

CONTACT

713 794 8906; pmandava@bcm.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 8, 2022
• First Posted: June 10, 2022
• Study Start: February 18, 2022
• Primary Completion: August 1, 2023
• Study Completion: May 31, 2024
• Last Updated: June 10, 2022

Record last verified: 2022-06

Locations

US (1)