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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00050817




Registration number
NCT00050817
Ethics application status
Date submitted
20/12/2002
Date registered
23/12/2002
Date last updated
23/04/2012

Titles & IDs
Public title
Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management and Avoidance (CHARISMA)
Scientific title
A Phase III, Multicenter, Multinational, Randomized, Parallel Group, Double-blind Trial of Clopidogrel Versus Placebo in High-risk Patients Aged 45 Years and Older, at Risk of Atherothrombotic Events, and Who Are Receiving Background Therapy Including Low-dose ASA.
Secondary ID [1] 0 0
EFC4505
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arteriosclerosis 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - clopidogrel (SR25990)

Treatment: Drugs: clopidogrel (SR25990)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Occurrence of myocardial infarction,stroke or cardiovascular death.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
severe bleeding
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
INCLUSION:

Be at least 45 years old and comply with at least one of the four categories of inclusion
criteria:

- Combination of atherothrombotic risk factors (2 major or 3 minor or 1 major + 2 minor
risk factors among those listed below)

Major atherothrombotic risk factors

- Type I or II diabetes (under drug therapy)

- Diabetic nephropathy

- Ankle brachial index (ABI) < 0.9

- Asymptomatic carotid stenosis >= 70%

- At least one carotid plaque as evidenced by intima-media thickness (IMT)

Minor atherothrombotic risk factors

- Systolic blood pressure (SBP) >= 150 mmHg, despite appropriate therapy for at least 3
months

- Primary hypercholesterolemia

- Current smoking > 15 cigarettes per day

- Male >= 65 years

- Female >= 70 years

and/or

- Documented cerebrovascular disease (TIA or IS within 5 years) and/or

- Documented coronary artery disease (stable angina with documented multivessel coronary
disease, previous documented MI, multivessel PCI or CABG within 1 year, multivessel
CABG older than 1 year associated with current angina) and/or

- Documented symptomatic PAD

EXCLUSION:

- Absolute indication for the use of clopidogrel, high-dose aspirin (>162 mg), NSAIDs,
or oral anti-thrombotic drugs

- Absolute contraindication to the use of clopidogrel or aspirin

- Clinical conditions likely to interfere with follow-up leading to inability to
complete the trial
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2005
Sample size
Target
Accrual to date
Final
15603
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Sanofi-aventis Administrative Office - Macquarie Park
Recruitment postcode(s) [1] 0 0
- Macquarie Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Ohio
Country [2] 0 0
Argentina
State/province [2] 0 0
Buenos Aires
Country [3] 0 0
Austria
State/province [3] 0 0
Wien
Country [4] 0 0
Belgium
State/province [4] 0 0
Diegem
Country [5] 0 0
Brazil
State/province [5] 0 0
Sao Paulo
Country [6] 0 0
Canada
State/province [6] 0 0
Laval
Country [7] 0 0
Chile
State/province [7] 0 0
Santiago
Country [8] 0 0
Czech Republic
State/province [8] 0 0
Praha
Country [9] 0 0
Denmark
State/province [9] 0 0
Horsholm
Country [10] 0 0
Finland
State/province [10] 0 0
Helsinki
Country [11] 0 0
France
State/province [11] 0 0
Paris
Country [12] 0 0
Germany
State/province [12] 0 0
Berlin
Country [13] 0 0
Greece
State/province [13] 0 0
Athens
Country [14] 0 0
Hong Kong
State/province [14] 0 0
Causeway Bay
Country [15] 0 0
Hungary
State/province [15] 0 0
Budapest
Country [16] 0 0
Italy
State/province [16] 0 0
Milano
Country [17] 0 0
Malaysia
State/province [17] 0 0
Kuala Lumpur
Country [18] 0 0
Mexico
State/province [18] 0 0
Mexico
Country [19] 0 0
Netherlands
State/province [19] 0 0
Gouda
Country [20] 0 0
Norway
State/province [20] 0 0
Lysaker
Country [21] 0 0
Poland
State/province [21] 0 0
Warszawa
Country [22] 0 0
Portugal
State/province [22] 0 0
Porto Salvo
Country [23] 0 0
Russian Federation
State/province [23] 0 0
Moscow
Country [24] 0 0
Singapore
State/province [24] 0 0
Singapore
Country [25] 0 0
South Africa
State/province [25] 0 0
Midrand
Country [26] 0 0
Spain
State/province [26] 0 0
Barcelona
Country [27] 0 0
Sweden
State/province [27] 0 0
Bromma
Country [28] 0 0
Switzerland
State/province [28] 0 0
Geneva
Country [29] 0 0
Taiwan
State/province [29] 0 0
Taipei
Country [30] 0 0
Turkey
State/province [30] 0 0
Istanbul
Country [31] 0 0
United Kingdom
State/province [31] 0 0
Guildford Surrey

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
RATIONALE:

- Atherothrombosis is a progressive and generalized vascular disease resulting in events
leading to myocardial infarction (heart attack), stroke, and vascular death.

- In patients at risk for this disease, it is characterized by an unpredictable, sudden
disruption of atherosclerotic plaques, which may lead to total occlusion of artery due
to formation of a clot. The use of aspirin (blood thinner agent) for reducing those
major ischemic events is either indicated, or recommended by international guidelines.
However, aspirin fails to prevent a high percentage of such life-threatening events.
Therefore, more effective blood thinning therapy may provide additional clinical benefit
to such patients.

- The results of the CURE trial in patients with unstable angina demonstrate the
additional benefit of long-term treatment (up to one year) with clopidogrel, (a blood
thinner agent), when administered in combination with standard therapy including
aspirin. The purpose of CHARISMA is to investigate whether a similar clinical benefit of
clopidogrel may apply to a broad population of high-risk patients receiving low-dose
aspirin therapy. Such population includes patients with previous cardiovascular,
neurovascular or peripheral arterial manifestations of atherothrombosis and patients
with combinations of recognized risk factors for atherosclerosis.

OBJECTIVES:

- To assess the efficacy of clopidogrel 75 mg once-daily by comparison with a placebo, in
preventing cardiovascular morbidity/mortality. The study will compare the efficacy of
the two regimens in preventing the occurrence of major cardiovascular complications
(stroke, heart attack, cardiovascular death) in high-risk patients who are otherwise
receiving low-dose aspirin therapy (75-162 mg daily).

- To evaluate the safety of clopidogrel in this population, and more specifically the
incidence of fatal or severe bleeding (as per GUSTO definition), in order to estimate
the global benefit of clopidogrel in this patient population.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00050817
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ICD CSD
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00050817