Local Versus Systemic Thrombolysis for Acute Ischemic Stroke (SYNTHESIS)

NCT00540527 | Completed Phase 3 DMC

• 1 other identifier: SYNTHESIS
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether intra-arterial rt-PA within 6 hours from an ischemic stroke onset, compared with intravenous infusion of the same drug within 3 hours, increases the proportion of independent survivors at 3 months.

Conditions

Stroke; Cerebrovascular Accident

Keywords

acute ischemic stroke;thrombolysis;intraarterial thrombolysis

Outcome Measures

Primary Outcomes (1)

• To assess whether local intra-arterial (LIA) recombinant tissue plasminogen activator rt-PA, as compared to intravenous (IV) rt-PA, increases survival free of disability (modified Rankin score of 0 or 1) .

  3 months

Study Arms (2)

1

EXPERIMENTAL

local intraarterial recombinant tissue plasminogen activator

Drug: local interarterial recombinant tissue plasminogen activator

2

ACTIVE COMPARATOR

intravenous (IV) rt-PA

Drug: intravenous (IV) rt-PA

Interventions

local interarterial recombinant tissue plasminogen activator DRUG

Endovascular treatment must be performed asap after random.and definitely within 6h from symp. onset.It includes intrarterial thrombolysis with rt-PA,if necessary,associated to or substituted by mechanical clot disruption and/or retrieval.Fibrinolytic therapy should be performed within 1h,the full dose of rt-PA infusion should not exceed 0.9 mg/kg (max 90 mg in the case of body weight ≥100 kg).If a complete recanalization is achieved,rt-PA infusion can be interrupted before reaching the maximum dosage.The option of performing a thrombolysis by mechanical means to obtain a mechanical disintegration/shift/detach/fissure of the thrombus and/or a retraction/aspiration can be considered on the basis of the type,location and characteristics of the occlusion.These choices may involve the use of the microguidewire as a mechanical instrument to favour the disintegration of the thrombus,using systems to capture the thrombus by extraction or more complex systems to crush and aspirate the thrombus

1

intravenous (IV) rt-PA DRUG

IV thrombolytic treatment is started immediately after randomization, within 4.5 h of symptoms onset. IV rt-PA is administered at a dose of 0.9 mg/kg (max 90 mg), 10% of which is given as a bolus, followed by the delivery of the remaining 90% as a constant infusion over 60 mins

2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sudden focal neurological deficit attributable to a stroke
• Clearly defined time of onset, allowing initiation of intravenous treatment within 3 hours of symptoms onset and intra-arterial treatment within 6 hour of symptoms onset.
• Age between 18 and 80 years

You may not qualify if:

• Disability preceding stroke consistent with a modified Rankin scale score of 2-4 (see glossary for Rankin scale)
• Coma at onset
• Severe stroke as assessed clinically (e.g. NIHSS\>25)
• Rapidly improving neurological deficit or minor symptoms
• Seizure at onset of stroke
• Clinical presentation suggestive of a subarachnoid hemorrhage (even of CT scan is normal) or condition after subarachnoid hemorrhage from aneurysm
• Previous history of or suspected intracranial hemorrhage
• Previous history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery)
• Septic embolism, bacterial endocarditis, pericarditis
• Acute pancreatitis
• Arterial puncture at a non compressible site (e.g. subclavian or jugular vein puncture) or traumatic external heart massage or obstetrical delivery within the previous 10 days
• Another stroke or serious head trauma within the preceding 3 months
• Major surgery or significant trauma in past 3 month
• Urinary tract hemorrhage within the previous 21 days
• Documented ulcerative gastrointestinal disease during the last 3 months, esophageal varices, arterial-aneurysm, arterial/venous malformations • Neoplasm with increased bleeding risk

Sponsors & Collaborators

• Niguarda Hospital: lead

Study Sites (1)

AO Ospedale Niguarda Ca' Granda

Milan, Milan, 20162, Italy

Location

Related Publications (1)

• Ciccone A, Valvassori L, Ponzio M, Ballabio E, Gasparotti R, Sessa M, Scomazzoni F, Tiraboschi P, Sterzi R; SYNTHESIS Investigators. Intra-arterial or intravenous thrombolysis for acute ischemic stroke? The SYNTHESIS pilot trial. J Neurointerv Surg. 2010 Mar;2(1):74-9. doi: 10.1136/jnis.2009.001388. Epub 2009 Oct 30.

  PMID: 21990564 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Alfonso Ciccone, MD

  Azienda Ospedaliera Ospedale Niguarda Ca' Granda

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2007
• First Posted: October 8, 2007
• Study Start: January 1, 2004
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: October 26, 2012

Record last verified: 2012-10

Locations

IT (1)