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ISRCTN
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ISRCTN62197120
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DOI
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10.1186/ISRCTN62197120
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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The Women's Hormone Intervention Secondary Prevention Pilot Study
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Scientific title
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Acronym
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WHISP
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Serial number at source
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G9811667
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Study hypothesis
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To determine the safety and tolerability of hormone replacement therapy (HRT) after acute myocardial infarction (MI) in post-menopausal women
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Lay summary
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Ethics approval
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Added 18/07/2007: North Thames Multicentre Research Ethics Committee and the Local Research Ethics Committee at each centre.
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Acute myocardial infarction (MI)
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Participants - inclusion criteria
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Post menopausal women (amenorrhoea for more than 12 months oestrogen deficiency symptoms) or more than 55 years, more than 48 hours and less than 7 days after the onset of acute Myocardial Infarction (MI) (Creatine Kinase [CK] twice upper limit or CKMB above the threshold considered diagnostic for myocardial damage in that centre) plus one of the two additional following criteria:
1. Admission for symptoms of acute myocardial ischaemia
2. Changes on the electrocardiogram supportive of a diagnosis of acute MI, provision of written informed consent
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Participants - exclusion criteria
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1. Unconfirmed MI
2. Use of HRT currently or previous 12 months, patients for whom clear indications for, of contraindications to, long term HRT
3. Increased risk of thromboembolism
4. Prior history of DVT or PE
5. BMI more than 32
6. Prolonged immobility
7. Known breast or endometrial cancer
8. Post-menopausal bleeding that has not been adequately investigated
9. Presence of non-cardiac condition influencing survival
10. Anticipated inability of the patient to comply with the study procedures
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Anticipated start date
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01/10/1999
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Anticipated end date
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01/12/2000
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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125
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Interventions
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Not provided at time of registration
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Primary outcome measure(s)
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Reinfarction, readmission, death
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Medical Research Council (UK)
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Trial website
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Publications
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2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16899475
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Contact name
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Dr
Marcus
Flather
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Address
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Clinical Trials & Evaluation Unit
Royal Brompton Hospital
Sydney Street
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City/town
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London
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Zip/Postcode
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SW3 6NP
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Country
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United Kingdom
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Email
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Sponsor
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Medical Research Council (MRC) (UK)
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Address
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20 Park Crescent
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City/town
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London
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Zip/Postcode
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W1B 1AL
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Country
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United Kingdom
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Tel
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+44 (0)20 7636 5422
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Fax
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+44 (0)20 7436 6179
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Email
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clinical.trial@headoffice.mrc.ac.uk
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Sponsor website:
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http://www.mrc.ac.uk
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Date applied
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25/10/2000
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Last edited
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11/09/2008
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Date ISRCTN assigned
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25/10/2000
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