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TIMI 10A

TIMI 10A. Protocol Design. Pt. with Acute MI < 12h. TNK- tPA Bolus. 8 Ascending. TNK-tPA Doses:. 5, 7.5, 10, 15, 20,. 30, 40, 50 mg. ASA + IV Heparin (APTT 55-85). End Points:. Pharmacokinetics. Coagulation parameters. TIMI grade 3 flow at 90'. TIMI frame count. Major hemorrhage.

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TIMI 10A

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  1. TIMI 10A Protocol Design Pt. with Acute MI < 12h TNK- tPA Bolus 8 Ascending TNK-tPA Doses: 5, 7.5, 10, 15, 20, 30, 40, 50 mg ASA + IV Heparin (APTT 55-85) End Points: Pharmacokinetics Coagulation parameters TIMI grade 3 flow at 90' TIMI frame count Major hemorrhage Follow-up Hosp. Discharge to 30 days Allergic Events Cannon CP et al. Circulation 1995;92:I-415.

  2. TIMI 10A Primary Results TIMI Flow Grade at 90 Minutes TNK-tPA Dose Cannon CP, TIMI 10A Investigators. Circulation 1997;95:351-6

  3. TIMI 10B Protocol Design Patient with Acute ST Elevation MI < 12 hours Randomize t-PA 100 mg TNK-tPA 30mg TNK-tPA 40mg TNK-tPA 50mg* *Stopped early Replaced with 40 mg ASA, IV Heparin Angio 60, 75, 90 Mins 30 Day Follow-up

  4. TIMI 10B Primary Results TIMI Flow Grade at 90 Minutes 88% 82% 79% 77% * N = 311 304 146 76 Cannon CP for the TIMI 10B Investigators. Circulation1998;98:2805-14

  5. ASSENT I Protocol Design Patient with Acute ST Elevation MI < 12 hours Randomize TNK-tPA 30mg TNK-tPA 40mg TNK-tPA 50mg* *Stopped early Replaced with 40 mg ASA, IV Heparin 30 Day Follow-up

  6. ASSENT I Primary Results Incidence of Stroke at 30 Days Van de Werf F, Cannon CPfor the ASSENT 1 InvestigatorsAmHeart J1999;137:786-91

  7. TIMI 10B/ASSENT I Adjunctive Therapy ICH Pre/post Reduction in Heparin p = 0.4 p = 0.01 p = 0.046 Giugliano RP, Circ 1997;96:I-535 (abstract)

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