1 / 13

Phases of Trial

Phases of Trial. Control. Investigational. tPA Phase (N= 888) (Circ 99 : 2720,1999). tPA. Accel tPA. Abx +.  SK. No lytic. Accel tPA. Abx + 50 mg tPA + LD/VLD Heparin. rPA Phase (N=299). rPA (10 +10 U). Abx +  rPA + LD/VLD Heparin.

jamal-tran
Download Presentation

Phases of Trial

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Phases of Trial Control Investigational tPA Phase (N= 888)(Circ 99 : 2720,1999) tPA Accel tPA Abx +  SK No lytic Accel tPA Abx + 50 mg tPA + LD/VLD Heparin rPA Phase (N=299) rPA (10 +10 U) Abx +  rPA + LD/VLD Heparin tPA + rPA Pooled Database (N=1187)

  2. ST  , lytic eligible, < 12 h ASA No Abciximab Abx: bolus 0.25 mg/kg inf 0.125 g/kg/min x 12 h ControlFull Dose Lytic:tPA 100 mgorrPA 10 + 10 U Reduced Dose Lytic  tPA, SK,rPA STD Heparin (70 U/kg ; 15 U/kg/h) Low Dose Heparin (60 U/kg ; 7 U/kg/h) Very Low Dose Heparin (30 U/kg ; 4 U/kg/h) Angio (90 min) , In Hospital Events, 30 day F/U

  3. TIMI 3 Flow (Core Lab) : 90 min

  4. TIMI 3 Flow (Core Lab) : 90 min

  5. Safety Observations:Dose Finding Phase N= 677 Major Hemorrhage* (6.6% --mostly instr.; ICH = 1.2%)tPA control 5%Abx alone 3%tPA + Abx 6%SK + Abx 10% (dose related increase) Thrombocytopenia <100K <50KtPA Control 3% 0.6%Reperf. reg. with Abx7% 1.4% Mortality (30 days) 4.0% --no important differences across groups  *Major Hemorrhage = ICH, Retroperitoneal, or Hg > 5 gm/dL

  6. Abciximab Improves the Speed and Extent of Thrombolysis: 60 + 90 min TIMI 3 Flow

  7. Abciximab Facilitates ThrombolysistPA Phase TIMI 3 Flow- 60 min TIMI Frame Count- 60 min 100 100 P=0.0009 P=0.001 80 80 72 60 60 % Pts 43 40 40 20 20 0 0 0 20 40 60 80 100 tPA 50 mg + Abx tPA 100 mg

  8. rPA rPA + Abx % Pts N = 87 88 75 10 + 10 U 5 + 5 U 10 + 5 U rPA dose TIMI 3 Flow : 90 minrPA Phase

  9. 50% Lytic+ Abx Full Dose Lytic P=0.014 % Pts N = 87 215 88 148 tPA100 mg rPA10 + 10 U tPA50 mg rPA5 + 5 U TIMI 3 Flow : 90 min tPA +rPA Phases

  10. Determinants of TIMI 3 flow at 90 MintPA + rPA pooled TIMI 3 Flow (N=610) O.R. (95 CI) 0.73 (0.51,1.04) LAD 0.93 (0.88,0.99) Time (per hour) Abciximab 1.57 (1.09,2.26)P=0.01 Non Significant Lytic 0.2 1 5 Less Likely More Likely O.R.

  11. Evaluation of Myocardial Perfusion 1. ST Resolution: Schröder JACC 26: 1657,1995 Complete (>70%) Partial (30-70%) None (< 30%) 2. TIMI Myocardial Perfusion Grade (MPG) TMP Grade 0 TMP Grade 1 TMP Grade 2 TMP Grade 3 No or minimal blush Stain present. Blush persists on next injection Dye strongly persistent at end of washout. Gone by next injection Normal ground glass appearance of blush. Dye mildly persistent at end of washout CM Gibson Circulation 1999

  12. Abciximab Improves Myocardial Perfusion tPA Phase rPA Phase Complete (> 70%) ST RES--90 min TMPG 2/390 min P=0.08 P<0.001 % Pts N=66 N=33 N=221 N=125 C.M. Gibson 1999 de Lemos et al AHA 1999

  13. Conclusions Reperfusion regimens to achieve TIMI 3 flow:1. Abciximab alone =full dose SK alone2. Abciximab augments rate and extent of thrombolysis with  dose lytics 60 min90 min tPA tPA (50 mg) tPA tPA (50 mg) 100mg + Abx 100mg + Abx TIMI 3 Flow 43% 72%* 62% 77%* 3. Safety profile encouraging * p=0.0009 unadjusted * p=0.01 unadjusted

More Related