Smoking CessationSTADIANCT00990197
The Safety of Transdermal Nicotine Immediately Following an Acute Coronary Syndrome
A study testing Transdermal nicotine patch in people with Smoking Cessation, run by Sir Mortimer B. Davis - Jewish General Hospital at 1 site in Canada.
Trial summary
Continuing to smoke after having a heart attack greatly increases the risk of death and cardiac illness. The nicotine patch is a commonly used pharmacotherapy for smoking cessation and has great potential to help heart attack patients quit smoking. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Transdermal nicotine patch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2005to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Current smoker, ≥ 10 cigarettes per day, on average, for the past year
- Suffered an enzyme-positive ACS (Troponin T, Troponin I, or CK-MD) and planned hospitalization of ≥ 48 hours
- Motivated to quit smoking
Who cannot join
- Current use of any medical therapy for smoking cessation
- History of alcohol or controlled substance abuse
- History of severe dermatitis
- Current diagnosis of unstable psychiatric illness requiring medication
- Suffered an ACS as a complication of a hospitalization for a different condition (i.e. postoperatively)
- Pregnancy or lactation
- Likely to be unavailable for follow-up
- Unable to read and understand English or French
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Safety of Transdermal Nicotine Immediately Following an Acute Coronary Syndrome: The STADIA Pilot Study
Continuing to smoke after having a heart attack greatly increases the risk of death and cardiac illness. The nicotine patch is a commonly used pharmacotherapy for smoking cessation and has great potential to help heart attack patients quit smoking. However, due to safety concerns, physicians are often hesitant to prescribe the nicotine patch to patients who have just suffered a heart attack. The STADIA pilot study will assess the feasibility of a large-scale clinical trial investigating safety and efficacy outcomes associated with the nicotine patch immediately following a heart attack. Eligible subjects will be randomized within 48 hours of suffering a heart attack to wear a transdermal nicotine patch on either day 1 or day 2 of the study period. The nicotine patch will deliver nicotine to the patient over the period of 24 hours. Patients will be advised to discuss smoking cessation strategies with their treating physician and subsequent care will be left to the discretion of this physician. The duration of ischemia (loss of blood flow in the heart), patient adherence, incidence of arrhythmia (disorder of the heart rate or rhythm), heart rate, and blood pressure within the two groups will be used to evaluate the safety of transdermal nicotine use immediately after a heart attack.
Read the detailed description
Objective
The STADIA Pilot Study will be used to evaluate the feasibility of conducting a three-year multi-centre trial investigating the long-term safety and efficacy outcomes associated with transdermal nicotine use immediately following an acute coronary syndrome (ACS).
Rationale
Patients who initially survive an ACS are at high risk of recurrent cardiac events or cardiovascular death. Within the first 6 months alone, 12% of patients will die or suffer another ACS, while another 23% will require revascularization for angina. Patients who are able to quit smoking reduce their chances of suffering a recurrent ACS or cardiovascular death within the next year by ≥ 50%. After surviving an ACS, most patients are highly motivated to stop smoking. However, as nicotine is an extremely addictive psychoactive drug, up to 60% of patients who attempt to quit relapse. Hospitalization following an ACS provides an opportunity for smokers to quit, as smoking while in hospital is prohibited. However, abstinence while hospitalized also precipitates intense nicotine withdrawal symptoms, which are largely responsible for the high rates of smoking relapse. Nicotine replacement therapy (NRT) can ameliorate many of these symptoms and increase the chances that smokers continue to abstain from tobacco use after discharge. Of the available NRTs, transdermal nicotine is associated with the least severe cardiovascular effects, as it delivers nicotine more gradually (with lower peak values) than nicotine gum or inhalers. Although transdermal nicotine more than doubles long-term smoking cessation rates when compared with placebo, it is rarely prescribed by physicians in the weeks immediately following an ACS because the possible cardiovascular effects of nicotine after an ACS have yet to be systematically evaluated.
Methods
A total of 30 patients will be randomized within 48-hours of suffering an ACS from the Jewish General Hospital (Montreal, QC) and collaborating centres. Prior to randomization, all patients will receive standardized smoking cessation counselling. Subjects who satisfy the inclusion and exclusion criteria for the trial will be randomized within 48 hours of suffering an ACS to wear a transdermal nicotine patch on either day 1 or day 2 of the study period. Subjects will apply a patch the morning of their treatment day and keep it on for 24 hours. Patients will be advised to discuss smoking cessation strategies with their treating physician and subsequent care will be left to the discretion of this physician. Twenty-four hour Holter monitoring will be used to measure heart rate, incidence of arrhythmia, and the duration of ischemic events at day 1 and day 2 of the study period. Systolic and diastolic blood pressure will be assessed via 24-hour Ambulatory blood pressure monitoring (ABPM). ABPM will be used on day 1 and day 2 of the study period. On day 1 the study nurse will record the severity of nicotine withdrawal symptoms, side effects, any smoking relapses and if so, how many cigarettes were smoked, and any medications they are currently taking. On day 7 and 14 patients will be contacted by telephone to determine the severity of nicotine withdrawal symptoms, any smoking relapses and if so, how many cigarettes were smoked and any medications they are currently taking. Cardiovascular events will be assessed by patient monitoring and by a study nurse. Nicotine withdrawal symptoms according to the Hughes-Hatsukami symptom scale and common nicotine patch side effects, severity-rated on a five-point scale, will be determined through study nurse inquiries on days 1, 7, and 14 (6). Carbon monoxide monitors will be used to measure levels of expired CO at baseline. Participants whose levels of expired CO exceed 10 ppm will be classified as smokers.
Significance
If shown to be safe and effective, transdermal nicotine will have a major impact on the secondary prevention of recurrent cardiac events on the 20,000 Canadian smokers who suffer an ACS each year.
- Conditions
- Smoking Cessation
- Being tested
- Transdermal nicotine patch
- Keywords
- Pilot study, Randomized clinical trial, Smoking cessation, Acute coronary syndrome, Transdermal nicotine patch
- Medical subject headings
- Smoking Cessation, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transdermal nicotine patchDrug
Also called Nicoderm CQ, Biovail Pharmaceuticals
Subjects will apply the nicotine patch on the morning of their treatment day and will keep it on for 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| Day 1 | Active comparator | Patients randomized to wearing the patch on day 1 will apply a patch on the morning of their treatment day and keep it on for 24 hours. These patients will not wear a patch on day 2. Receives: Drug: Transdermal nicotine patch |
| Day 2 | Active comparator | Patients randomized to wearing the patch on day 2 will apply a patch on the morning of their treatment day and keep it on for 24 hours. These patients will not wear a patch on day 1. Receives: Drug: Transdermal nicotine patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total duration of ischemic episodes
Measured: Day 1 and Day 2
Secondary outcomes (4)
Patient adherence to study protocol
Measured: Day 1, Day 7, Day 14
Incidence of arrhythmia
Measured: Day 1 and Day 2
Heart rate
Measured: Day 1 and Day 2
Systolic and diastolic blood pressure
Measured: Day 1 and Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2009 (estimated)
- Study startJun 2005
- Primary completionJul 2009 (estimated)
- Study completionDec 2009 (estimated)
Why it stopped: Difficulties with enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (55)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sir Mortimer B. Davis - Jewish General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Tobacco Control Research Initiative
- Investigators
- Mark J Eisenberg, MD MPH, Principal investigator, Jewish General Hospital/McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00990197
- Sponsor's protocol ID
- 05-023
- Other IDs
- 016026
- Acronym
- STADIA
- Status last verified
- Oct 2009
- First submitted
- 5 Oct 2009
- Last updated
- 6 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sauer WH, Berlin JA, Strom BL, Miles C, Carson JL, Kimmel SE. Cigarette yield and the risk of myocardial infarction in smokers. Arch Intern Med. 2002 Feb 11;162(3):300-6. doi: 10.1001/archinte.162.3.300.
PubMed 11822922Cardiovascular Disease Surveillance. Laboratory Centre for Disease Control, Statistics Canada 2002, Candian Institutes for Health Information (CIHI), 2002.
Nicotine replacement therapy for patients with coronary artery disease. Working Group for the Study of Transdermal Nicotine in Patients with Coronary artery disease. Arch Intern Med. 1994 May 9;154(9):989-95.
PubMed 8179456Frid D, Ockene IS, Ockene JK, Merriam P, Goldberg R, Kristeller J, Barrett S. Severity of angiographically proven coronary artery disease predicts smoking cessation. Am J Prev Med. 1991 May-Jun;7(3):131-5.
PubMed 1931139Brummett BH, Babyak MA, Mark DC, Williams RB, Siegler IC, Clapp-Channing N, Barefoot JC. Predictors of smoking cessation in patients with a diagnosis of coronary artery disease. J Cardiopulm Rehabil. 2002 May-Jun;22(3):143-7. doi: 10.1097/00008483-200205000-00003.
PubMed 12042680Hughes JR. Tobacco withdrawal in self-quitters. J Consult Clin Psychol. 1992 Oct;60(5):689-97. doi: 10.1037//0022-006x.60.5.689.
PubMed 1401384Stapleton J. Cigarette smoking prevalence, cessation and relapse. Stat Methods Med Res. 1998 Jun;7(2):187-203. doi: 10.1177/096228029800700206.
PubMed 9654641Rigotti NA, Arnsten JH, McKool KM, Wood-Reid KM, Pasternak RC, Singer DE. Smoking by patients in a smoke-free hospital: prevalence, predictors, and implications. Prev Med. 2000 Aug;31(2 Pt 1):159-66. doi: 10.1006/pmed.2000.0695.
PubMed 10938217Jorenby DE, Hatsukami DK, Smith SS, Fiore MC, Allen S, Jensen J, Baker TB. Characterization of tobacco withdrawal symptoms: transdermal nicotine reduces hunger and weight gain. Psychopharmacology (Berl). 1996 Nov;128(2):130-8. doi: 10.1007/s002130050118.
PubMed 8956374Benowitz NL, Fitzgerald GA, Wilson M, Zhang Q. Nicotine effects on eicosanoid formation and hemostatic function: comparison of transdermal nicotine and cigarette smoking. J Am Coll Cardiol. 1993 Oct;22(4):1159-67. doi: 10.1016/0735-1097(93)90431-y.
PubMed 7691912Mulligan SC, Masterson JG, Devane JG, Kelly JG. Clinical and pharmacokinetic properties of a transdermal nicotine patch. Clin Pharmacol Ther. 1990 Mar;47(3):331-7. doi: 10.1038/clpt.1990.36.
PubMed 2311334Gourlay S. The pros and cons of transdermal nicotine therapy. Med J Aust. 1994 Feb 7;160(3):152-9.
PubMed 8295585Benowitz NL. Drug therapy. Pharmacologic aspects of cigarette smoking and nicotine addiction. N Engl J Med. 1988 Nov 17;319(20):1318-30. doi: 10.1056/NEJM198811173192005. No abstract available.
PubMed 3054551Kaijser L, Berglund B. Effect of nicotine on coronary blood-flow in man. Clin Physiol. 1985 Dec;5(6):541-52. doi: 10.1111/j.1475-097x.1985.tb00767.x.
PubMed 4092414Transdermal nicotine for smoking cessation. Six-month results from two multicenter controlled clinical trials. Transdermal Nicotine Study Group. JAMA. 1991 Dec 11;266(22):3133-8.
PubMed 1956099
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety of Transdermal Nicotine Immediately Following an Acute Coronary Syndrome: The STADIA Pilot Study
- ClinicalTrials.gov ID
- NCT00990197
- Acronym / sponsor ID
- STADIA / 05-023
- Conditions
- Smoking Cessation
- Keywords
- Pilot study, Randomized clinical trial, Smoking cessation, Acute coronary syndrome, Transdermal nicotine patch
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Difficulties with enrollment.
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sir Mortimer B. Davis - Jewish General HospitalUniversity, hospital or other
- Collaborators
- Canadian Tobacco Control Research Initiative
- Study start
- Jun 2005
- Primary completion
- Jul 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 6 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Continuing to smoke after having a heart attack greatly increases the risk of death and cardiac illness. The nicotine patch is a commonly used pharmacotherapy for smoking cessation and has great potential to help heart attack patients quit smoking. However, due to safety concerns, physicians are often hesitant to prescribe the nicotine patch to patients who have just suffered a heart attack. The STADIA pilot study will assess the feasibility of a large-scale clinical trial investigating safety and efficacy outcomes associated with the nicotine patch immediately following a heart attack. Eligible subjects will be randomized within 48 hours of suffering a heart attack to wear a transdermal nicotine patch on either day 1 or day 2 of the study period. The nicotine patch will deliver nicotine to the patient over the period of 24 hours. Patients will be advised to discuss smoking cessation strategies with their treating physician and subsequent care will be left to the discretion of this physician. The duration of ischemia (loss of blood flow in the heart), patient adherence, incidence of arrhythmia (disorder of the heart rate or rhythm), heart rate, and blood pressure within the two groups will be used to evaluate the safety of transdermal nicotine use immediately after a heart attack.
Detailed description
Objective
The STADIA Pilot Study will be used to evaluate the feasibility of conducting a three-year multi-centre trial investigating the long-term safety and efficacy outcomes associated with transdermal nicotine use immediately following an acute coronary syndrome (ACS).
Rationale
Patients who initially survive an ACS are at high risk of recurrent cardiac events or cardiovascular death. Within the first 6 months alone, 12% of patients will die or suffer another ACS, while another 23% will require revascularization for angina. Patients who are able to quit smoking reduce their chances of suffering a recurrent ACS or cardiovascular death within the next year by ≥ 50%. After surviving an ACS, most patients are highly motivated to stop smoking. However, as nicotine is an extremely addictive psychoactive drug, up to 60% of patients who attempt to quit relapse. Hospitalization following an ACS provides an opportunity for smokers to quit, as smoking while in hospital is prohibited. However, abstinence while hospitalized also precipitates intense nicotine withdrawal symptoms, which are largely responsible for the high rates of smoking relapse. Nicotine replacement therapy (NRT) can ameliorate many of these symptoms and increase the chances that smokers continue to abstain from tobacco use after discharge. Of the available NRTs, transdermal nicotine is associated with the least severe cardiovascular effects, as it delivers nicotine more gradually (with lower peak values) than nicotine gum or inhalers. Although transdermal nicotine more than doubles long-term smoking cessation rates when compared with placebo, it is rarely prescribed by physicians in the weeks immediately following an ACS because the possible cardiovascular effects of nicotine after an ACS have yet to be systematically evaluated.
Methods
A total of 30 patients will be randomized within 48-hours of suffering an ACS from the Jewish General Hospital (Montreal, QC) and collaborating centres. Prior to randomization, all patients will receive standardized smoking cessation counselling. Subjects who satisfy the inclusion and exclusion criteria for the trial will be randomized within 48 hours of suffering an ACS to wear a transdermal nicotine patch on either day 1 or day 2 of the study period. Subjects will apply a patch the morning of their treatment day and keep it on for 24 hours. Patients will be advised to discuss smoking cessation strategies with their treating physician and subsequent care will be left to the discretion of this physician. Twenty-four hour Holter monitoring will be used to measure heart rate, incidence of arrhythmia, and the duration of ischemic events at day 1 and day 2 of the study period. Systolic and diastolic blood pressure will be assessed via 24-hour Ambulatory blood pressure monitoring (ABPM). ABPM will be used on day 1 and day 2 of the study period. On day 1 the study nurse will record the severity of nicotine withdrawal symptoms, side effects, any smoking relapses and if so, how many cigarettes were smoked, and any medications they are currently taking. On day 7 and 14 patients will be contacted by telephone to determine the severity of nicotine withdrawal symptoms, any smoking relapses and if so, how many cigarettes were smoked and any medications they are currently taking. Cardiovascular events will be assessed by patient monitoring and by a study nurse. Nicotine withdrawal symptoms according to the Hughes-Hatsukami symptom scale and common nicotine patch side effects, severity-rated on a five-point scale, will be determined through study nurse inquiries on days 1, 7, and 14 (6). Carbon monoxide monitors will be used to measure levels of expired CO at baseline. Participants whose levels of expired CO exceed 10 ppm will be classified as smokers.
Significance
If shown to be safe and effective, transdermal nicotine will have a major impact on the secondary prevention of recurrent cardiac events on the 20,000 Canadian smokers who suffer an ACS each year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Day 1 | Active comparator | Drug: Transdermal nicotine patchPatients randomized to wearing the patch on day 1 will apply a patch on the morning of their treatment day and keep it on for 24 hours. These patients will not wear a patch on day 2. |
| Day 2 | Active comparator | Drug: Transdermal nicotine patchPatients randomized to wearing the patch on day 2 will apply a patch on the morning of their treatment day and keep it on for 24 hours. These patients will not wear a patch on day 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Current smoker, ≥ 10 cigarettes per day, on average, for the past year
- Suffered an enzyme-positive ACS (Troponin T, Troponin I, or CK-MD) and planned hospitalization of ≥ 48 hours
- Motivated to quit smoking
Key exclusion criteria (8 listed)
- Current use of any medical therapy for smoking cessation
- History of alcohol or controlled substance abuse
- History of severe dermatitis
- Current diagnosis of unstable psychiatric illness requiring medication
- Suffered an ACS as a complication of a hospitalization for a different condition (i.e. postoperatively)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transdermal nicotine patchAlso: Nicoderm CQ, Biovail PharmaceuticalsSubjects will apply the nicotine patch on the morning of their treatment day and will keep it on for 24 hours. | Drug | Day 1, Day 2 |
Primary outcome
The total duration of ischemic episodes
Time frame: Day 1 and Day 2
4 secondary outcomes
Patient adherence to study protocol
Time frame: Day 1, Day 7, Day 14
Incidence of arrhythmia
Time frame: Day 1 and Day 2
Heart rate
Time frame: Day 1 and Day 2
Systolic and diastolic blood pressure
Time frame: Day 1 and Day 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2009.
- Background: PubMed 11822922Sauer WH, Berlin JA, Strom BL, Miles C, Carson JL, Kimmel SE. Cigarette yield and the risk of myocardial infarction in smokers. Arch Intern Med. 2002 Feb 11;162(3):300-6. doi: 10.1001/archinte.162.3.300.
- BackgroundCardiovascular Disease Surveillance. Laboratory Centre for Disease Control, Statistics Canada 2002, Candian Institutes for Health Information (CIHI), 2002.
- Background: PubMed 8179456Nicotine replacement therapy for patients with coronary artery disease. Working Group for the Study of Transdermal Nicotine in Patients with Coronary artery disease. Arch Intern Med. 1994 May 9;154(9):989-95.
- Background: PubMed 1931139Frid D, Ockene IS, Ockene JK, Merriam P, Goldberg R, Kristeller J, Barrett S. Severity of angiographically proven coronary artery disease predicts smoking cessation. Am J Prev Med. 1991 May-Jun;7(3):131-5.
- Background: PubMed 12042680Brummett BH, Babyak MA, Mark DC, Williams RB, Siegler IC, Clapp-Channing N, Barefoot JC. Predictors of smoking cessation in patients with a diagnosis of coronary artery disease. J Cardiopulm Rehabil. 2002 May-Jun;22(3):143-7. doi: 10.1097/00008483-200205000-00003.
- Background: PubMed 1401384Hughes JR. Tobacco withdrawal in self-quitters. J Consult Clin Psychol. 1992 Oct;60(5):689-97. doi: 10.1037//0022-006x.60.5.689.
- Background: PubMed 9654641Stapleton J. Cigarette smoking prevalence, cessation and relapse. Stat Methods Med Res. 1998 Jun;7(2):187-203. doi: 10.1177/096228029800700206.
- Background: PubMed 10938217Rigotti NA, Arnsten JH, McKool KM, Wood-Reid KM, Pasternak RC, Singer DE. Smoking by patients in a smoke-free hospital: prevalence, predictors, and implications. Prev Med. 2000 Aug;31(2 Pt 1):159-66. doi: 10.1006/pmed.2000.0695.
- Background: PubMed 8956374Jorenby DE, Hatsukami DK, Smith SS, Fiore MC, Allen S, Jensen J, Baker TB. Characterization of tobacco withdrawal symptoms: transdermal nicotine reduces hunger and weight gain. Psychopharmacology (Berl). 1996 Nov;128(2):130-8. doi: 10.1007/s002130050118.
- Background: PubMed 7691912Benowitz NL, Fitzgerald GA, Wilson M, Zhang Q. Nicotine effects on eicosanoid formation and hemostatic function: comparison of transdermal nicotine and cigarette smoking. J Am Coll Cardiol. 1993 Oct;22(4):1159-67. doi: 10.1016/0735-1097(93)90431-y.
- Background: PubMed 2311334Mulligan SC, Masterson JG, Devane JG, Kelly JG. Clinical and pharmacokinetic properties of a transdermal nicotine patch. Clin Pharmacol Ther. 1990 Mar;47(3):331-7. doi: 10.1038/clpt.1990.36.
- Background: PubMed 8295585Gourlay S. The pros and cons of transdermal nicotine therapy. Med J Aust. 1994 Feb 7;160(3):152-9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark J Eisenberg, MD MPH principal investigator
Jewish General Hospital/McGill University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transdermal nicotine patch in people with Smoking Cessation, run by Sir Mortimer B. Davis - Jewish General Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 6 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The total duration of ischemic episodes (time frame: Day 1 and Day 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00990197, which also lists 55 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2009.