The Women's Hormone Intervention Secondary Prevention Pilot Study

ISRCTN	ISRCTN62197120
DOI	https://doi.org/10.1186/ISRCTN62197120
Protocol serial number	G9811667
Sponsor	Medical Research Council (MRC) (UK)
Funder	Medical Research Council (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Marcus Flather
Scientific

Clinical Trials & Evaluation Unit
Royal Brompton Hospital
Sydney Street
London
SW3 6NP
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	WHISP
Study objectives	To determine the safety and tolerability of hormone replacement therapy (HRT) after acute myocardial infarction (MI) in post-menopausal women
Ethics approval(s)	Added 18/07/2007: North Thames Multicentre Research Ethics Committee and the Local Research Ethics Committee at each centre.
Health condition(s) or problem(s) studied	Acute myocardial infarction (MI)
Intervention	Not provided at time of registration
Intervention type	Other
Primary outcome measure(s)	Reinfarction, readmission, death
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/12/2000

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	125
Key inclusion criteria	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
Key exclusion criteria	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
Date of first enrolment	01/10/1999
Date of final enrolment	01/12/2000

Clinical Trials & Evaluation Unit

London
SW3 6NP
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2006		Yes	No