title: Efficiency of enrollment in a successful phase II acute stroke clinical trial.
abstract: BACKGROUND
  Recruitment challenges are common in acute stroke clinical trials. In a population-based study, we determined eligibility and actual enrollment for a successful, phase II acute stroke clinical trial. We hypothesized that missed opportunities for enrollment of eligible patients occurred frequently, despite the success of the trial.
  
  
  METHODS
  In 2005, acute ischemic stroke (AIS) cases in our region were identified at all 17 local hospitals as part of an epidemiologic study. The Combined Approach to Lysis Utilizing Eptifibatide and Recombinant Tissue Plasminogen Activator (CLEAR) trial assessed the safety of this combination in AIS patients within 3 hours of symptom onset. In 2005, we determined the proportion of AIS patients who were eligible for CLEAR and the proportion that were actually enrolled.
  
  
  RESULTS
  At 8 participating hospitals, 33 (2.8%) of 1175 AIS patients were eligible for CLEAR. Of 33 eligible patients, 18 (54.5%) were approached for enrollment, 4 (12.1%) refused, 1 (3.0%) was not consentable, and 13 (39.4%) were enrolled. Of the 15 not approached for enrollment in the trial, 10 were evaluated by the stroke team; 7 received recombinant tissue plasminogen activator. Enrollment was not associated with night or weekend presentation.
  
  
  CONCLUSIONS
  Although the CLEAR trial was successful in meeting its delineated recruitment goals, our findings suggest enrollment could have been more efficient. Three out of 4 patients approached for enrollment participated in the trial. Eligible patients who were not approached and those treated with recombinant tissue plasminogen activator but not enrolled represent targets for improving enrollment rates.
authors: Department of Emergency Medicine and Neurosurgery, University of Cincinnati Neuroscience Institute, Cincinnati, Ohio 45267-0525, USA. opeolu.adeoye@uc.edu
authors: Opeolu
authors: O
authors: Adeoye
authors: Arthur
authors: A
authors: Pancioli
authors: Jane
authors: J
authors: Khoury
authors: Charles J
authors: CJ
authors: Moomaw
authors: Pamela
authors: P
authors: Schmit
authors: Irene
authors: I
authors: Ewing
authors: Kathleen
authors: K
authors: Alwell
authors: Matthew L
authors: ML
authors: Flaherty
authors: Daniel
authors: D
authors: Woo
authors: Simona
authors: S
authors: Ferioli
authors: Pooja
authors: P
authors: Khatri
authors: Joseph P
authors: JP
authors: Broderick
authors: Brett M
authors: BM
authors: Kissela
authors: Dawn
authors: D
authors: Kleindorfer
mesh_terms: D000368:Aged; D017322:Clinical Trials, Phase II as Topic / Q000379:methods*; D004359:Drug Therapy, Combination; D004608:Eligibility Determination; D000077542:Eptifibatide; D005260:Female; D005343:Fibrinolytic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007629:Kentucky; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic / Q000379:methods*; D009820:Ohio; D018579:Patient Selection; D010455:Peptides / Q000008:administration & dosage* / Q000009:adverse effects; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012189:Retrospective Studies; D018401:Sample Size; D020521:Stroke / Q000175:diagnosis / Q000188:drug therapy*; D015912:Thrombolytic Therapy / Q000009:adverse effects; D010959:Tissue Plasminogen Activator / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D005343:Fibrinolytic Agents; D010455:Peptides; D010959:Tissue Plasminogen Activator; D000077542:Eptifibatide