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Information about SPARCL

Published on October 18, 2016

Author: IsabellaLai


1. SPARCL OVMC LANDMARK TRIALS SERIES Amarenco P, et al. "High-dose atorvastatin after stroke or transient ischemic attack". The New England Journal of Medicine. 2006. 355(6):549-559.

2. STROKE PREVENTION by Aggressive Reduction in Cholesterol Levels (SPARCL)

3. BACKGROUND  CARE, LIPID, and 4S trials showed that the role of statins in primary prevention of stroke and TIA in patients with high risk CVA  However, prior to SPARCL, there were not clear guidelines for secondary prevention of stroke and TIA Primary Prevention • Well population • Address risk factors • Education and prevention • Eg: Immunizations, exercise programs Secondary Prevention • People at risk of health problem • Screening at risk groups • Intervention and medication to control risk factors and early intervention Tertiary Prevention • People with a health problem • Rehab, preventing complications and improving quality of life

4. CLINICAL QUESTION For patients prior stroke or TIA, does HIGH-DOSE ATORVASTATIN reduce the risk of recurrent stroke?

5. DESIGN  Analysis: Intention-to-treat  Multicenter, double blind, parallel-group, randomized, placebo-controlled trial  N=4,731 patients with prior stroke/TIA  Atorvastatin (n=2,365)  Placebo (n=2,366)  Setting: 205 centers  Enrollment: 1998-2001  Mean follow-up: 4.9 years  Primary outcome: fatal or non-fatal stroke

6. POPULATION Inclusion Criteria  Age ≥18 years  Ischemic stroke, hemorrhagic stroke, or TIA in the 1-6 months before randomization  TIAs diagnosed by a neurologist within 30 days of the primary event  Those with hemorrhagic stroke thought to be at risk for ischemic stroke or CAD by the investigator  Modified Rankin score ≤3  LDL 100-190 mg/dL (2.59-4.92 mmol/L) Exclusion Criteria  Non-ambulatory  Atrial fibrillation  Cardiac sources of embolism  Subarachnoid hemorrhage  While not a strict exclusion criterion, patients with LDL >160 mg/dL (4.14 mmol/L) were excluded in 15 of 205 centers

7. INTERVENTIONS  Cessation of any lipid-lowering medications 30 days before screening  Randomization to atorvastatin 80mg PO daily or placebo  Counseling on the National Cholesterol Education Program Step 1 or similar diets throughout the study  Visits on months 1, 3, and 6 months and every 6 months subsequently  Labs and EKGs at screening, at regular intervals during study, and at completion of the study

8. CRITICISMS  Power of SPARCL study not sufficient to assess mortality  SPARCL did not have a run-in period (period when placebo is given); for that reason, it is harder to assess tolerability of high-dose atorvastatin in SPARCL

9. BOTTOM LINE In patients with prior stroke/TIA, Atorvastatin reduces risk of recurrent ischemic stroke BUT may increase risk of hemorrhagic stroke

10. DISCUSSION QUESTIONS  For a patient with history of ischemic stroke, would you give Atorvastatin? When would you re-consider giving Atrovastatin?  What is a run-in period?

11. DISCUSSION QUESTIONS  For a patient with history of ischemic stroke, would you give Atorvastatin?  ANSWER: Yes, give High-dose Atorvastatin 40mg or 80mg  When would you re-consider giving Atorvastatin?  ANSWER: For patients with ischemic stroke  What is a run-in period?  Period before trial begins when no treatment is given Screen & Consent RUN-IN Period (Placebo given) Randomization! Group A Group B Placebo responders, non-compliant participants, participants intolerant of medications, etc Satisfactory DROPPED!

12. BOARD-LIKE QUESTION 77yo F, hx HTN, HLD presented to ED with left facial droop and left sided weakness. Emergent CT scan showed no bleed. MRI showed evidence of right MCA CVA. The following day, PE showed HR 91, BP 138/62, RR 14 bpm, sating 100% on RA. Nuchal rigidity is present. Patient responds to loud voice. Finger stick glucose over 24 hours shows 140-179 mg/dL. Which treatment would help reduce risk of recurrent stroke? A. IV dopamine B. IV insulin C. Oral Atorvastatin D. Oral Nimodipine

13. BOARD-LIKE QUESTION Educational Objective: Statin use in ischemic stroke and TIA Key Point: - Statins are used in ischemic stroke or TIA from atherosclerotic subtype as it reduces risk of recurrent stroke - Efficacy of statins for secondary stroke prevention or neuroprotective agent in subarachoid hemorrhage has not been established - Nimodipine (L-type calcium channel blocker) helps prevent neurologic complications after subarachoid hemorrhage by reducing vasospam in clinical trials ANSWER Which treatment would help reduce risk of recurrent stroke? A. IV dopamine B. IV insulin C. Oral Atorvastatin D. Oral Nimodipine

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