Myocardial InfarctionPhase 3NCT00245648
Female Sex is an Independent Predictor of Death and Bleeding Among Fibrinolytic Treated Patients With AMI
A Phase 3 study testing fibrinolytic therapy or combination reduced fibrinolytic therapy in people with Myocardial Infarction, run by NYU Langone Health at 1 site in United States.
Trial summary
This study evaluated differences between men and women in the presentation, management and outcome of heart attacks within the GUSTO V study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- fibrinolytic therapy or combination reduced fibrinolytic therapy
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Jun 2001to Oct 2007
- Phase
- Phase 3
- 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
None listed.
Who cannot join
- lack of availability of data (database study)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Female Sex is an Independent Predictor of Death and Bleeding Among Fibrinolytic Treated Patients With AMI; Results of the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries - V Trial
This study evaluated differences between men and women in the presentation, management and outcome of heart attacks within the GUSTO V study.
Read the detailed description
The Global Use of Strategies to Open Occluded Arteries in Acute Coronary Syndromes (GUSTO) V trial examined a large, contemporary cohort of women and men with ST elevation myocardial infarction (STEMI) treated with fibrinolytic therapy. The objective of the present study was to evaluate sex differences in presentation, management and outcome in GUSTO V.
- Conditions
- Myocardial Infarction
- Being tested
- fibrinolytic therapy or combination reduced fibrinolytic therapy
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fibrinolytic therapy or combination reduced fibrinolytic therapyDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome
All cause mortality at 30 days after randomization.
Measured: 30 days
Secondary outcomes (1)
Secondary Outcomes
Incidence of myocardial reinfarction as evidenced by new electrocardiographic changes or elevation in cardiac enzyme levels with recurrent chest pain within 7 days, bleeding, stoke, intracranial hemorrhage (ICH), and complications of MI.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2005 (estimated)
- Study startJun 2001
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- The Cleveland Clinic, Centocor, Inc., Eli Lilly and Company
- Responsible party
- Principal investigator, Harmony R. Reynolds, NYU Langone Health
- Investigators
- Harmony Reynolds, Principal investigator, NYU School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00245648
- Sponsor's protocol ID
- GUSTOVsex
- Status last verified
- Oct 2012
- First submitted
- 27 Oct 2005
- Last updated
- 4 Oct 2012
- Results posted
- No
Publications
Topol EJ; GUSTO V Investigators. Reperfusion therapy for acute myocardial infarction with fibrinolytic therapy or combination reduced fibrinolytic therapy and platelet glycoprotein IIb/IIIa inhibition: the GUSTO V randomised trial. Lancet. 2001 Jun 16;357(9272):1905-14. doi: 10.1016/s0140-6736(00)05059-5.
PubMed 11425410Lincoff AM, Califf RM, Van de Werf F, Willerson JT, White HD, Armstrong PW, Guetta V, Gibler WB, Hochman JS, Bode C, Vahanian A, Steg PG, Ardissino D, Savonitto S, Bar F, Sadowski Z, Betriu A, Booth JE, Wolski K, Waller M, Topol EJ; Global Use of Strategies To Open Coronary Arteries Investigators (GUSTO). Mortality at 1 year with combination platelet glycoprotein IIb/IIIa inhibition and reduced-dose fibrinolytic therapy vs conventional fibrinolytic therapy for acute myocardial infarction: GUSTO V randomized trial. JAMA. 2002 Nov 6;288(17):2130-5. doi: 10.1001/jama.288.17.2130.
PubMed 12413372Reynolds HR, Farkouh ME, Lincoff AM, Hsu A, Swahn E, Sadowski ZP, White JA, Topol EJ, Hochman JS; GUSTO V Investigators. Impact of female sex on death and bleeding after fibrinolytic treatment of myocardial infarction in GUSTO V. Arch Intern Med. 2007 Oct 22;167(19):2054-60. doi: 10.1001/archinte.167.19.2054.
PubMed 17954798
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Female Sex is an Independent Predictor of Death and Bleeding Among Fibrinolytic Treated Patients With AMI; Results of the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries - V Trial
- ClinicalTrials.gov ID
- NCT00245648
- Acronym / sponsor ID
- GUSTOVsex
- Conditions
- Myocardial Infarction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- The Cleveland Clinic, Centocor, Inc., Eli Lilly and Company
- Study start
- Jun 2001
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 28 Oct 2005 (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.
This study evaluated differences between men and women in the presentation, management and outcome of heart attacks within the GUSTO V study.
Detailed description
The Global Use of Strategies to Open Occluded Arteries in Acute Coronary Syndromes (GUSTO) V trial examined a large, contemporary cohort of women and men with ST elevation myocardial infarction (STEMI) treated with fibrinolytic therapy. The objective of the present study was to evaluate sex differences in presentation, management and outcome in GUSTO V.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- lack of availability of data (database study)
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 |
|---|---|---|
| fibrinolytic therapy or combination reduced fibrinolytic therapy | Drug | – |
Primary outcome
Primary Outcome
Time frame: 30 days
All cause mortality at 30 days after randomization.
1 secondary outcome
Secondary Outcomes
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2012.
- Background: PubMed 11425410Topol EJ; GUSTO V Investigators. Reperfusion therapy for acute myocardial infarction with fibrinolytic therapy or combination reduced fibrinolytic therapy and platelet glycoprotein IIb/IIIa inhibition: the GUSTO V randomised trial. Lancet. 2001 Jun 16;357(9272):1905-14. doi: 10.1016/s0140-6736(00)05059-5.
- Background: PubMed 12413372Lincoff AM, Califf RM, Van de Werf F, Willerson JT, White HD, Armstrong PW, Guetta V, Gibler WB, Hochman JS, Bode C, Vahanian A, Steg PG, Ardissino D, Savonitto S, Bar F, Sadowski Z, Betriu A, Booth JE, Wolski K, Waller M, Topol EJ; Global Use of Strategies To Open Coronary Arteries Investigators (GUSTO). Mortality at 1 year with combination platelet glycoprotein IIb/IIIa inhibition and reduced-dose fibrinolytic therapy vs conventional fibrinolytic therapy for acute myocardial infarction: GUSTO V randomized trial. JAMA. 2002 Nov 6;288(17):2130-5. doi: 10.1001/jama.288.17.2130.
- Derived from this study: PubMed 17954798Reynolds HR, Farkouh ME, Lincoff AM, Hsu A, Swahn E, Sadowski ZP, White JA, Topol EJ, Hochman JS; GUSTO V Investigators. Impact of female sex on death and bleeding after fibrinolytic treatment of myocardial infarction in GUSTO V. Arch Intern Med. 2007 Oct 22;167(19):2054-60. doi: 10.1001/archinte.167.19.2054.
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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.
Harmony Reynolds principal investigator
NYU School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing fibrinolytic therapy or combination reduced fibrinolytic therapy in people with Myocardial Infarction, run by NYU Langone Health at 1 site in United States.
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 0 inclusion and 1 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: finished, as of the sponsor's last update on 4 Oct 2012. 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 United States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Primary Outcome (time frame: 30 days). 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 NCT00245648, which also lists 3 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 4 Oct 2012.