NCT00640367

Brief Summary

SYNTHESIS is a pragmatic multicenter randomized controlled trial (RCT), open-label, with blinded follow-up aiming to determine whether loco-regional intra-arterial (IA) with recombinant tissue-plasminogen activator (rt-PA) and/or mechanical devices, as compared with systemic intravenous (I.V.) infusion of rt-PA within 3 hours of ischemic stroke, increases the proportion of independent survivors at 3 months.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P50-P75 for phase_3 stroke

Timeline
Completed

Started Feb 2008

Typical duration for phase_3 stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 21, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

April 25, 2014

Status Verified

April 1, 2014

Enrollment Period

1 year

First QC Date

March 18, 2008

Last Update Submit

April 24, 2014

Conditions

StrokeCerebrovascular Accident

Keywords

Acute ischemic strokethrombolysisintra-arterial thrombolysis

Outcome Measures

Primary Outcomes (1)

  • To assess whether IA thrombolysis, as compared to IV rt-PA, increases survival free of disability (modified Rankin score of zero or 1) at 3 months.

    3 months

Secondary Outcomes (1)

  • To asses whether IA thrombolysis vs.IV rt-PA 1.improves the 7 day neurological deficit; 2.is safe on the base of symptomatic intracranial hemorrhages, fatal and non-fatal stroke, death from any cause, neurological deterioration within 7 days

    7 days

Study Arms (2)

IA thrombolysis

EXPERIMENTAL

IA recombinant tissue plasminogen activator and/or mechanical thrombolysis

Other: Alteplase IA and/or mechanical thrombolysis

IV rtPA

ACTIVE COMPARATOR

IV recombinant tissue plasminogen activator

Drug: Alteplase IV

Interventions

Alteplase IA and/or mechanical thrombolysisOTHER

loca intra-arterial recombinant tissue plasminogen activator and/or mechanical thrombolysis

IA thrombolysis
Alteplase IVDRUG

intravenous recombinant tissue plasminogen activator

IV rtPA

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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 greater than 18 years

You may not qualify if:

  • Disability preceding stroke consistent with a modified Rankin scale score of 2-4
  • Coma at onset
  • Rapidly improving neurological deficit
  • Seizure at onset
  • Clinical presentation suggestive of a subarachnoid hemorrhage
  • Previous history of intracranial hemorrhage
  • Septic embolism
  • Arterial puncture at a non compressible site within the previous 7 days
  • Any traumatic brain injury within the previous 14 days
  • Surgery of the central nervous system in the previous 3 months
  • Gastrointestinal hemorrhage or urinary tract hemorrhage within the previous 14 days.
  • Current therapy with intravenous or subcutaneous heparin to rise the clotting time
  • Known hereditary or acquired hemorrhagic diathesis, baseline INR greater than 1.5, aPTT more than 1.5 times normal, or baseline platelet count less than 100,000 per cubic millimeter
  • Baseline blood glucose concentrations below 2.75 mm/L (50 mg/dL).
  • Known contrast sensitivity.
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

A.O. Ospedale Ca' Granda

Milan, Milan, 20162, Italy

Location

Related Publications (1)

  • Ciccone A, Valvassori L, Nichelatti M, Sgoifo A, Ponzio M, Sterzi R, Boccardi E; SYNTHESIS Expansion Investigators. Endovascular treatment for acute ischemic stroke. N Engl J Med. 2013 Mar 7;368(10):904-13. doi: 10.1056/NEJMoa1213701. Epub 2013 Feb 6.

    PMID: 23387822DERIVED

MeSH Terms

Conditions

StrokeIschemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Alfonso Ciccone, MD

    A.O. 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

March 18, 2008

First Posted

March 21, 2008

Study Start

February 1, 2008

Primary Completion

February 1, 2009

Study Completion

July 1, 2012

Last Updated

April 25, 2014

Record last verified: 2014-04

Locations

IT(1)