Interventional Management of Stroke (IMS) III Trial

• Status: Terminated
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare two different treatment approaches to recanalization started within 3 hours of symptom onset-combined intravenous (IV) and endovascular therapy and standard intravenous (IV) rt-PA alone.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Joseph Broderick
• Collaborators: Medical University of South Carolina; National Institute of Neurological Disorders and Stroke (NINDS); University of Calgary
• Treatments: Plasminogen; Tissue Plasminogen Activator

Criteria

Inclusion Criteria

• Age: 18 through 82 years (i.e., candidates must have had their 18th birthday, but not had their 83rd birthday)

• Initiation of intravenous rt-PA within 3 hours of onset of stroke symptoms. Time of onset is defined as the last time when the subject was witnessed to be at baseline (i.e., subjects who have stroke symptoms upon awakening will be considered to have their onset at beginning of sleep)

• An NIHSSS >/= 10 at the time that intravenous rt-PA is begun or an NIHSSS >7 and <10 with an occlusion seen in M1, ICA or basilar artery on CTA at institutions where baseline CTA imaging is standard of care for acute stroke patients.

• Investigator verification that the subject has received/ is receiving the correct IV rt-PA dose for the estimated weight prior to randomization

Exclusion Criteria

• History of stroke in the past 3 months

• Previous intra-cranial hemorrhage, neoplasm, subarachnoid hemorrhage, or arteriovenous malformation

• Clinical presentation suggests a subarachnoid hemorrhage, even if initial CT scan is normal

• Hypertension at time of treatment; systolic BP > 185 or diastolic > 110 mm Hg) or aggressive measures to lower BP to below these limits are needed.

• Presumed septic embolus, or suspicion of bacterial endocarditis

• Presumed pericarditis, including pericarditis after acute MI

• Suspicion of aortic dissection

• Recent (within 30 days) surgery or biopsy of parenchymal organ

• Recent (within 30 days) trauma, with internal injuries or ulcerative wounds

• Recent (within 90 days) severe head trauma or head trauma with loss of consciousness

• Any active or recent (within 30 days) hemorrhage

• Pts with known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency or oral anticoagulant therapy require coagulation labs results prior to enrollment. Any subject with INR > 1.7 or institutionally equivalent prothrombin time is excluded. Patients without history or suspicion of coagulopathy do not require INR or prothrombin time lab results to be available prior to enrollment.

• Females of childbearing potential who are known to be pregnant and/or lactating or who have positive pregnancy tests on admission

• Baseline lab values: glucose < 50 mg/dl or > 400 mg/dl, platelets <100,000, or Hct <25

• Requires hemodialysis or peritoneal dialysis, or has a contraindication to an angiogram for whatever reason

• Received heparin or a direct thrombin inhibitor (Angiomax, argatroban, Refludan, Pradaxa) within 48 hours must have a normal partial thromboplastin time (PTT) to be eligible

• History of an arterial puncture at a non-compressible site or a lumbar puncture in the previous 7 days

• History of seizure at onset of stroke

• History of a pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations, mRS score at baseline must be < 2. This excludes patients who live in a nursing home or who are not fully independent for activities of daily living (toileting, dressing, eating, cooking and preparing meals, etc.)

• Other serious, advanced, or terminal illness

• Any other condition that the investigator feels would pose a significant hazard to the subject if Activase (Alteplase) therapy is initiated

• Current participation in another research drug treatment protocol

• Informed consent is not or cannot be obtained.

• High density lesion consistent with hemorrhage of any degree on baseline imaging

• Significant mass effect with midline shift on baseline imaging

• Large (>1/3 of the middle cerebral artery) regions of clear hypodensity on the baseline CT scan. (ASPECTS of < 4 can be used as a guideline) Sulcal effacement and/or loss of grey-white differentiation are not contraindications to tx

• CT evidence of intrapararenchymal tumor

• Baseline CTA without evidence of arterial occlusion