Condition category
Circulatory System
Date applied
25/10/2000
Date assigned
25/10/2000
Last edited
11/09/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Marcus Flather

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G9811667

Study information

Scientific title

Acronym

WHISP

Study hypothesis

To determine the safety and tolerability of hormone replacement therapy (HRT) after acute myocardial infarction (MI) in post-menopausal women

Ethics approval

Added 18/07/2007: North Thames Multicentre Research Ethics Committee and the Local Research Ethics Committee at each centre.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Acute myocardial infarction (MI)

Intervention

Not provided at time of registration

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Reinfarction, readmission, death

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/10/1999

Overall trial end date

01/12/2000

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

125

Participant 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

Recruitment start date

01/10/1999

Recruitment end date

01/12/2000

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Clinical Trials & Evaluation Unit
London
SW3 6NP
United Kingdom

Sponsor information

Organisation

Medical Research Council (MRC) (UK)

Sponsor details

20 Park Crescent
London
W1B 1AL
United Kingdom
+44 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16899475

Publication citations

  1. Results

    Collins P, Flather M, Lees B, Mister R, Proudler AJ, Stevenson JC, , Randomized trial of effects of continuous combined HRT on markers of lipids and coagulation in women with acute coronary syndromes: WHISP Pilot Study., Eur. Heart J., 2006, 27, 17, 2046-2053, doi: 10.1093/eurheartj/ehl183.

Additional files

Editorial Notes