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Intracoronary KAI-9803 as an Adjunct to Primary Percutaneous Coronary Intervention for Acute ST-Segment Elevation Myocardial Infarction

Bates, Eric ; Bode, Christoph ; Costa, Marco ; Gibson, C Michael ; Granger, Christopher ; Green, Cindy ; Grimes, Kevin ; Harrington, Robert ; Huber, Kurt ; Kleiman, Neal ; Mochly-Rosen, Daria ; Roe, Matthew ; Sadowski, Zygmunt ; Solomon, Scott ; Widimsky, Petr

Circulation (New York, N.Y.), 2008-02, Vol.117 (7), p.886-896 [Periódico revisado por pares]

Hagerstown, MD: Lippincott Williams & Wilkins

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Título:
Intracoronary KAI-9803 as an Adjunct to Primary Percutaneous Coronary Intervention for Acute ST-Segment Elevation Myocardial Infarction
Autor: Bates, Eric ; Bode, Christoph ; Costa, Marco ; Gibson, C Michael ; Granger, Christopher ; Green, Cindy ; Grimes, Kevin ; Harrington, Robert ; Huber, Kurt ; Kleiman, Neal ; Mochly-Rosen, Daria ; Roe, Matthew ; Sadowski, Zygmunt ; Solomon, Scott ; Widimsky, Petr
Assuntos: Angioplasty, Balloon, Coronary ; Biological and medical sciences ; Biomarkers ; Blood and lymphatic vessels ; Cardiology. Vascular system ; Cardiovascular Agents - administration & dosage ; Cardiovascular Agents - adverse effects ; Cardiovascular Agents - therapeutic use ; Chemotherapy, Adjuvant ; Cohort Studies ; Combined Modality Therapy ; Coronary Angiography ; Coronary heart disease ; Coronary Vessels ; Diseases of the peripheral vessels. Diseases of the vena cava. Miscellaneous ; Dose-Response Relationship, Drug ; Double-Blind Method ; Electrocardiography ; Female ; Heart ; Humans ; Injections, Intra-Arterial ; Male ; Medical sciences ; Middle Aged ; Myocardial Infarction - blood ; Myocardial Infarction - diagnostic imaging ; Myocardial Infarction - drug therapy ; Myocardial Infarction - pathology ; Myocardial Infarction - surgery ; Myocardial Reperfusion ; Peptides - administration & dosage ; Peptides - adverse effects ; Peptides - therapeutic use ; Protein Kinase C-delta - antagonists & inhibitors ; Protein Kinase Inhibitors - administration & dosage ; Protein Kinase Inhibitors - adverse effects ; Protein Kinase Inhibitors - therapeutic use
É parte de: Circulation (New York, N.Y.), 2008-02, Vol.117 (7), p.886-896
Descrição: KAI-9803, a delta-protein kinase C inhibitor, has been shown to ameliorate injury associated with ischemia and reperfusion in animal models of acute myocardial infarction (MI). Direct Inhibition of delta-Protein Kinase C Enzyme to Limit Total Infarct Size in Acute Myocardial Infarction (DELTA MI) was a "first-in-human," dose-escalation study that evaluated the safety, tolerability, and activity of KAI-9803 for patients with acute anterior ST-segment elevation MI undergoing primary percutaneous coronary intervention. Patients who presented within 6 hours of symptom onset and had an occluded left anterior descending infarct artery on angiography were randomized in a 2:1 fashion to receive 1 of 4 doses of KAI-9803 (cohort 1, 0.05 mg; cohort 2, 0.5 mg; cohort 3, 1.25 mg; cohort 4, 5.0 mg) versus blinded concurrent placebo delivered in 2 divided doses via intracoronary injection before and after reestablishment of antegrade epicardial flow with percutaneous coronary intervention. Safety and biomarker end points were assessed. Overall, 154 patients were randomized and treated with study drug (37 in cohort 1, 38 in cohort 2, 38 in cohort 3, 41 in cohort 4). The incidence of serious adverse events was similar between patients treated with KAI-9803 versus placebo. Other safety end points, including changes in QT intervals and standard laboratory values after study drug administration, were similar between treatment groups. Although the study was not powered to demonstrate efficacy with the biomarker end points assessed, signs of drug activity with KAI-9803 were suggested by trends for consistent, nonsignificant reductions in creatine kinase-MB area under the curve and ST-recovery area under the curve values across all dosing cohorts with KAI-9803 compared with concurrent placebo, and similar trends were demonstrated for improvements in (99m)technetium sestamibi infarct size values with active study drug in cohorts 1, 2, and 3. KAI-9803 had an acceptable safety and tolerability profile when delivered via intracoronary injection during primary percutaneous coronary intervention for ST-segment elevation MI. Signs of potential drug activity were demonstrated with biomarker end points in this small exploratory study, indicating that further testing of KAI-9803 as an adjunctive therapy for ST-segment elevation MI is warranted.
Editor: Hagerstown, MD: Lippincott Williams & Wilkins
Idioma: Inglês

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Intracoronary KAI-9803 as an Adjunct to Primary Percutaneous Coronary Intervention for Acute ST-Segment Elevation Myocardial Infarction

Bates, Eric ; Bode, Christoph ; Costa, Marco ; Gibson, C Michael ; Granger, Christopher ; Green, Cindy ; Grimes, Kevin ; Harrington, Robert ; Huber, Kurt ; Kleiman, Neal ; Mochly-Rosen, Daria ; Roe, Matthew ; Sadowski, Zygmunt ; Solomon, Scott ; Widimsky, Petr

Hagerstown, MD: Lippincott Williams & Wilkins

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