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ACCESS A cute C andesartan C ilexetil E valuation in S troke S urvivors

ACCESS A cute C andesartan C ilexetil E valuation in S troke S urvivors. Early vs. delayed antihypertensive treatment with candesartan cilexetil in acute stroke patients with elevated BP. A double blind, randomized, placebo controlled multicenter study. Investigators:

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ACCESS A cute C andesartan C ilexetil E valuation in S troke S urvivors

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  1. ACCESSAcute Candesartan Cilexetil Evaluation in Stroke Survivors Early vs. delayed antihypertensive treatment with candesartan cilexetil in acute stroke patients with elevated BP A double blind, randomized, placebo controlled multicenter study Investigators: J. Schrader/Cloppenburg P. Dominiak/Lbeck

  2. ACCESSAcute Candesartan Cilexetil Evaluation in Stroke Survivors Objective To compare the effect of an early (36-72 hrs post event) vs.a delayed (> 7 days post event) antihypertensive treatment with candesartan cilexetil in acute stroke with elevated BP. Hypothesis An early treatment with candesartan cilexetil improves the prognosis (mortality plus disability) of acute stroke patients with hypertension.

  3. ACCESSAcute Candesartan Cilexetil Evaluation in Stroke Survivors Primary endpoint Total mortality and disability (functional status defined asBarthel Index £ 45) after 3 months. Secondary endpoint Combined criterion of - total mortality - cerebral complications - cardiovascular complications assessed 3 and 12 months after randomization

  4. ACCESSAcute Candesartan Cilexetil Evaluation in Stroke Survivors • Patients, inclusion criteria • 500 patients with • acute cerebral ischemia • motor paresis • hypertension (initial BP > 200/110 mmHg) • full consciousness

  5. ACCESSAcute Candesartan Cilexetil Evaluation in Stroke Survivors • Exclusion criteria (1) • Age > 85 years • History of cerebral ischaemia (apart from TIA) • Intracerebral haemorrhage • Internal carotid artery (ICA) occlusion or stenosis > 70% • Malignant hypertension (constant increase in DBP>120 mmHg) • Atrial fibrillation • Manifest heart failure (NYHA III-IV) • High grade aortic and mitral stenosis • Unstable angina pectoris • Pregnant and breast-feading women • Women in whom pregnancy during the study cannot be excluded

  6. ACCESSAcute Candesartan Cilexetil Evaluation in Stroke Survivors • Exclusion criteria (2) • Progressive, potentially fatal illness (life expectancy < 1 year) • Alcohol abuse, drugs • Severe hepatic impairment, Quick < 60% • Renal failure, creatinine > 3 mg% • Hypersensitivity to Candesartan • History of Quincke‘s oedema • Patients treated during the 3 months preceeding the study with other investigational substance • Patients already included once in the study • Legal incapacity and inability to give informed consent

  7. ACCESS Acute Candesartan Cilexetil Evaluation in Stroke Survivors Study design: • High BP in early phase of stroke, > 200 • and/or > 110 mmHg once or > 180 and /or • > 105 mmHg mean of 2 measurements • Treatment (Atacand/Placebo) initiated • within 72 hours of stroke • Dose-titration 4-8-16 mg, double blind • treatment for 7 days followed by open • treatment, 12 months follow up

  8. ACCESSAcute Candesartan Cilexetil Evaluation in Stroke Survivors Candesartan* Candesartan* Cerebral Ischemia Hypertension (>200/110 mmHg) Placebo Candesartan* 36/72 hrs. Day 7 3. month 1 year * 4 -16 mg according to BP, combination therapy if needed (HCT, CCB, Betablocker)

  9. ACCESSAcute Candesartan Cilexetil Evaluation in Stroke Survivors Study design: + additional therapy (HCT, Felodipine, Metoprolol) cc 16 cc 8 cc 4 R cc 4 - 8 - 16 - comb. Placebo 0 1d 2d 3d 7d 3m 6m 9m 12 m E E E Placebo controlled phase

  10. ACCESSAcute Candesartan Cilexetil Evaluation in Stroke Survivors Preliminary results: In March 2001, the study has prematurely been stopped witha total of 339 patients due to a significant difference infrequency of secondary endpoints between the two treatmentgroups.

  11. ACCESSAcute Candesartan Cilexetil Evaluation in Stroke Survivors Results: • > 90 % treated with Atacand after double-blind period • Disability at 3 months not affected (primary endpoint). • Total mortality + vascular events at 12 months reduced by 48 %, from 18,7 % to 9,8 %, p < 0,02, in the early treatment group (reason for early stop, secondary endpoint).

  12. ACCESSAcute Candesartan Cilexetil Evaluation in Stroke Survivors Results:

  13. ACCESS Acute Candesartan Cilexetil Evaluation in Stroke Survivors 0.2 Placebo -47.5% Precentage Mortality/Vasular events 0.1 Atacand n=339 p<0.05 0.0 0 100 200 300 400 Days

  14. ACCESSAcute Candesartan Cilexetil Evaluation in Stroke Survivors Early treatment with Atacand was safe in hypertensive stroke patients Long-term benefits may be related to early start of treatment with Atacand

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