Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000236594
Ethics application status
Approved
Date submitted
16/01/2006
Date registered
14/06/2006
Date last updated
14/06/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Placebo controlled,randomised,crossover study of the efficacy of dipyridamole in the management of angina in patients with Coronary Slow Flow Phenomenon
Scientific title
Placebo controlled, randomised, crossover study of the efficacy of dipyridamole in reducing the number of angina episodes in patients with Coronary Slow Flow Phenomenon (CSFP)
Universal Trial Number (UTN)
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Slow Flow Phenomenon 1213 0
Condition category
Condition code
Cardiovascular 1298 1298 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Dipyridamole 200mgs orally twice daily for 10 weeks ie 5 weeks of each treatment blinded.After 5 weeks of treatment patients would cross over to opposite treatment.Patients and study staff(excluding study pharmacist) remain blinded to the study drug throughout the duration of the study.
Intervention code [1] 841 0
Treatment: Drugs
Comparator / control treatment
Placebo
Control group
Placebo

Outcomes
Primary outcome [1] 1773 0
Angina frequency (total number of episodes of chest pain as recorded in a diary by the patient)
Timepoint [1] 1773 0
Measured and recorded at the end of each of the 2 phases
Secondary outcome [1] 3125 0
Nitrate consumption.
Timepoint [1] 3125 0
Measured at the end of each of the 2 phases.
Secondary outcome [2] 3126 0
Quality of life indices.
Timepoint [2] 3126 0
Measured at the end of each of the 2 phases.

Eligibility
Key inclusion criteria
Coronary slow flow phenomenon. Frequent angina(> 3 episodes per week).
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Significant haemorrhagic risk.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
numbered containers allocated to patients via fax to unblinded pharmacist
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generated via computer in permuted blocks
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2002
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
16
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1424 0
Hospital
Name [1] 1424 0
The Queen Elizabeth Hospital,Cardiology Unit
Country [1] 1424 0
Primary sponsor type
Hospital
Name
The Queen Elizabeth Hospital,Cardiology Unit
Address
Country
Australia
Secondary sponsor category [1] 1252 0
Commercial sector/Industry
Name [1] 1252 0
Boehringer Ingelheim
Address [1] 1252 0
Country [1] 1252 0
Germany

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2798 0
The Queen Elizabath Hospital
Ethics committee address [1] 2798 0
Ethics committee country [1] 2798 0
Australia
Date submitted for ethics approval [1] 2798 0
Approval date [1] 2798 0
24/01/2002
Ethics approval number [1] 2798 0

Summary
Brief summary
To assess if dipyridamole reduces the frequency of angina in patient with CSFP.
Study pharmacist was the only person unblinded to study treatment. Blinding was achieved by using pre numbered study drug containers and by fax randomisation to study pharmacist who would then allocate the study drug to the patient who is also blinded
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35150 0
Address 35150 0
Country 35150 0
Phone 35150 0
Fax 35150 0
Email 35150 0
Contact person for public queries
Name 10030 0
Dr John Beltrame
Address 10030 0
The Queen Elizabeth Hospital
28 Woodville Rd
Woodville SA 5011
Country 10030 0
Australia
Phone 10030 0
+61 8 82226000
Fax 10030 0
+61 8 82227201
Email 10030 0
[email protected]
Contact person for scientific queries
Name 958 0
Dr John Beltrame
Address 958 0
The Queen Elizabeth Hospital
28 Woodville Rd
Woodville SA 5011
Country 958 0
Australia
Phone 958 0
+61 8 82226000
Fax 958 0
+61 8 82227021
Email 958 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.