ST-segment Elevation Myocardial InfarctionPhase 4VALIDATENCT02311231
Bivalirudin vs Heparin in NSTEMI and STEMI in Patients on Modern Antiplatelet Therapy in SWEDEHEART
A Phase 4 study testing bivalirudin and Heparin in people with ST-segment Elevation Myocardial Infarction and Non ST-segment Elevation Myocardial Infarction, run by Uppsala University at 1 site in Sweden.
Trial summary
In this trial we test the hypothesis that PCI and bivalirudin is superior to heparin alone (according to local protocol) in reducing death, MI, and major bleeding in patients with NSTEMI or STEMI at 180 days (primary end point), treated with ticagrelor or prasugrel. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ST-segment Elevation Myocardial Infarction, Non ST-segment Elevation Myocardial Infarction
- What is being tested?
- bivalirudin and Heparin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,012 participants
- Where
- 1 siteSweden
- Study dates
- Jun 2014to Mar 2017
- Phase
- Phase 4
- 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
- Patients with a diagnosis of NSTEMI as judged by the physician in accordance with current guideline definitions (positive troponin) or, patients with a diagnosis of STEMI as defined by chest pain suggestive for myocardial ischemia for at least 30 minutes before hospital admission, time from onset of symptoms of less than 24 hours, and an ECG with new ST-segment elevation in two or more contiguous leads of ≥0.2 mV in leads V2-V3 and/or ≥0.1 mV in other leads or a probable new-onset left bundle branch block.
- PCI of culprit lesion is intended (therapeutic PCI, not primarily diagnostic PCI).
- Treated with bolus dose of ticagrelor or prasugrel before start of PCI. See 2.6
- Ability to provide informed consent
- Age 18 years or older
Who cannot join
- Previous randomization in the VALIDATE-SWEDEHEART trial.
- Known terminal disease with life expectancy less than one year.
- Patients with known ongoing bleeding
- Patients with uncontrolled hypertension in the opinion of the investigator
- Patients with known subacute bacterial endocarditis
- Patients with known severe renal (GFR < 30 ml/min) and/or liver dysfunction
Show all 10Show fewer
- Patients with known thrombocytopenia or thrombocyte function defects
- Any other contraindication for the study medications.
- Heparin > 5000U Before arriving to PCI lab or > 3000 U given during angiography before randomization.
- GpIIb/IIIa inhibitors have been given or are pre-planned to be given during the procedure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bivalirudin vs Heparin in NSTEMI and STEMI in Patients on Modern Antiplatelet Therapy in SWEDEHEART A Multicenter, Prospective, Randomized Controlled Clinical Trial Based on the SWEDEHEART Platform
In this trial we test the hypothesis that PCI and bivalirudin is superior to heparin alone (according to local protocol) in reducing death, MI, and major bleeding in patients with NSTEMI or STEMI at 180 days (primary end point), treated with ticagrelor or prasugrel.
Read the detailed description
The follow up of endpoints will be performed using SWEDEHEART and national registries. Follow up of primary endpoints and stroke will also be performed by telephone contacts with the patients or first degree relatives by a nurse phone call after 7 days and 180 days. The nurses will also accumulate hospital record information on these endpoints.
A central adjudication will be performed for all reported primary endpoints for the first 180 days follow up. Every site will prepare source documents for the event and send it to UCR for central adjudication by an independent committee.
- Conditions
- ST-segment Elevation Myocardial Infarction, Non ST-segment Elevation Myocardial Infarction
- Being tested
- bivalirudin, Heparin
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bivalirudinDrug
Also called Angiox
Will be administered as an intravenous bolus of 0.75 mg per kilogram, followed by an infusion of 1.75 mg per kilogram per hour). Bivalirudin will be administered alone or with a low dose of heparin up to 3000U heparin in lab or up to 5000 U given pre-hospital according to local practice.
HeparinDrug
Also called Heparin 5000 IU/ml i.v. ,Leo Pharma
Treatment with unfractionated Heparin 5000 IU/ml i.v. ,Leo Pharma, Sweden, (the control group). Heparin in the control group is administered as an intravenous or intra-arterial bolus according to local practice. A dose of 70-100 U/kg is recommended
| Study group | Role | What they receive |
|---|---|---|
| bivalirudin | Experimental | bivalirudin as intravenous bolus of 0,75 mg per kilogram followed by an infusion of 1,75 mg per kilogram per hour Receives: Drug: bivalirudin |
| heparin | Active comparator | unfractionated Heparin 5 000 IU/ml as intravenous bolus according to local practice Receives: Drug: Heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death, Myocardial infarction and major bleeding event
Measured: 180 days
Secondary outcomes (16)
Death, Myocardial infarction and major bleeding events in the subgroups NSTEMI and STEMI
Measured: 180 days
Time to primary endpoints (death, myocardial infarction and major bleeding event)
Time to individual components of the primary end point (death, myocardial infarction and major bleeding).
Measured: 180 days
Number of events where primary endpoints (death, myocardial infarction and major bleeding event) and stroke have been registered
The primary end point combined with stroke as reported in the Swedish national patient registry.
Measured: 180 days
Number of events where primary endpoints (death, myocardial infarction and major bleeding event) have been registered in heparin subgroups (U/kg, groups with certain max ACT values etc)
Measured: 180 days
TIMI flow grade after PCI
Measured: 180 days
Time to re-hospitalization with reinfarction
Time to re-hospitalization with reinfarction as reported in Swedeheart
Measured: 180 days
Time to all-cause death or re-hospitalization with myocardial infarction
Measured: 180 days
Time to target vessel revascularization
Time to target vessel revascularization as reported in SWEDEHEART.
Measured: 180 days
Time to target lesion revascularization
Time to target lesion revascularization as reported in SWEDEHEART
Measured: 180 days
Time to stent thrombosis
Time to stent thrombosis as reported in SWEDEHEART.
Measured: 180 days
Time to restenosis
Time to restenosis as reported in SWEDEHEART.
Measured: 180 days
Time to re-hospitalization with heart failure
Time to re-hospitalization with heart failure as reported in SWEDEHEART.
Measured: 180 days
Heart failure and complications of PCI during index hospitalization
Heart failure and complications of PCI during index hospitalization as reported in SWEDEHEART
Measured: 180 days
Minor bleeding during index hospitalization
Minor bleeding during index hospitalization as reported in SWEDEHEART
Measured: 180 days
Length of index hospital stay
Length of index hospital stay as reported in SWEDEHEART
Measured: 180 days
Bail-out use of GpIIb/IIIa
Bail-out use of GpIIb/IIIa inhibitors during PCI
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2014 (estimated)
- Study startJun 2014
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for ST-segment Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6,012 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University
- Responsible party
- Sponsor
- Investigators
- David Erlinge, Principal investigator, Lund University, Lund, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02311231
- Sponsor's protocol ID
- EudraCT nr: 2012-005260-10
- Acronym
- VALIDATE
- Status last verified
- May 2017
- First submitted
- 27 Nov 2014
- Last updated
- 19 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Omerovic E, James S, Ramundal T, Frobert O, Linder R, Danielewicz M, Hamid M, Pagonis C, Henareh L, Wagner H, Stewart J, Jensen J, Lindros P, Robertsson L, Wikstrom H, Ulvenstam A, Bhiladval P, Todt T, Ioanes D, Kellerth T, Zagozdzon L, Gotberg M, Andersson J, Angeras O, Ostlund O, Held C, Koul S, Erlinge D. Bivalirudin versus heparin in ST and non-ST-segment elevation myocardial infarction-Outcomes at two years. Cardiovasc Revasc Med. 2024 Sep;66:43-50. doi: 10.1016/j.carrev.2024.03.025. Epub 2024 Mar 26.
PubMed 38575449James S, Koul S, Andersson J, Angeras O, Bhiladvala P, Calais F, Danielewicz M, Frobert O, Grimfjard P, Gotberg M, Henareh L, Ioanes D, Jensen J, Linder R, Lindroos P, Omerovic E, Panayi G, Ramunddal T, Sarno G, Ulvenstam A, Voltz S, Wagner H, Wikstrom H, Ostlund O, Erlinge D. Bivalirudin Versus Heparin Monotherapy in ST-Segment-Elevation Myocardial Infarction. Circ Cardiovasc Interv. 2021 Dec;14(12):e008969. doi: 10.1161/CIRCINTERVENTIONS.120.008969. Epub 2021 Dec 14.
PubMed 34903034Bergman S, Mohammad MA, James SK, Angeras O, Wagner H, Jensen J, Schersten F, Frobert O, Koul S, Erlinge D. Clinical Impact of Intraprocedural Stent Thrombosis During Percutaneous Coronary Intervention in Patients Treated With Potent P2Y12 inhibitors - a VALIDATE-SWEDEHEART Substudy. J Am Heart Assoc. 2021 Sep 21;10(18):e022984. doi: 10.1161/JAHA.121.022984. Epub 2021 Sep 13.
PubMed 34514849Rylance RT, Wagner P, Omerovic E, Held C, James S, Koul S, Erlinge D. Assessing the external validity of the VALIDATE-SWEDEHEART trial. Clin Trials. 2021 Aug;18(4):427-435. doi: 10.1177/17407745211012438. Epub 2021 May 20.
PubMed 34011198Jamaly S, Redfors B, Omerovic E, Carlsson L, Karason K. Prognostic significance of BMI after PCI treatment in ST-elevation myocardial infarction: a cohort study from the Swedish Coronary Angiography and Angioplasty Registry. Open Heart. 2021 Feb;8(1):e001479. doi: 10.1136/openhrt-2020-001479.
PubMed 33589539Olsson A, Ring C, Josefsson J, Eriksson A, Rylance R, Frobert O, James S, Sparv D, Erlinge D. Patient experience of the informed consent process during acute myocardial infarction: a sub-study of the VALIDATE-SWEDEHEART trial. Trials. 2020 Mar 6;21(1):246. doi: 10.1186/s13063-020-4147-0.
PubMed 32143733Wester A, Attar R, Mohammad MA, Andell P, Hofmann R, Jensen J, Szummer K, Erlinge D, Koul S. Impact of Baseline Anemia in Patients With Acute Coronary Syndromes Undergoing Percutaneous Coronary Intervention: A Prespecified Analysis From the VALIDATE-SWEDEHEART Trial. J Am Heart Assoc. 2019 Aug 20;8(16):e012741. doi: 10.1161/JAHA.119.012741. Epub 2019 Aug 7.
PubMed 31387441Erlinge D, Omerovic E, Frobert O, Linder R, Danielewicz M, Hamid M, Swahn E, Henareh L, Wagner H, Hardhammar P, Sjogren I, Stewart J, Grimfjard P, Jensen J, Aasa M, Robertsson L, Lindroos P, Haupt J, Wikstrom H, Ulvenstam A, Bhiladvala P, Lindvall B, Lundin A, Todt T, Ioanes D, Ramunddal T, Kellerth T, Zagozdzon L, Gotberg M, Andersson J, Angeras O, Ostlund O, Lagerqvist B, Held C, Wallentin L, Schersten F, Eriksson P, Koul S, James S. Bivalirudin versus Heparin Monotherapy in Myocardial Infarction. N Engl J Med. 2017 Sep 21;377(12):1132-1142. doi: 10.1056/NEJMoa1706443. Epub 2017 Aug 27.
PubMed 28844201
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bivalirudin vs Heparin in NSTEMI and STEMI in Patients on Modern Antiplatelet Therapy in SWEDEHEART A Multicenter, Prospective, Randomized Controlled Clinical Trial Based on the SWEDEHEART Platform
- ClinicalTrials.gov ID
- NCT02311231
- Acronym / sponsor ID
- VALIDATE / EudraCT nr: 2012-005260-10
- Conditions
- ST-segment Elevation Myocardial Infarction, Non ST-segment Elevation Myocardial Infarction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,012 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Lund University
- Study start
- Jun 2014
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 8 Dec 2014 (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.
In this trial we test the hypothesis that PCI and bivalirudin is superior to heparin alone (according to local protocol) in reducing death, MI, and major bleeding in patients with NSTEMI or STEMI at 180 days (primary end point), treated with ticagrelor or prasugrel.
Detailed description
The follow up of endpoints will be performed using SWEDEHEART and national registries. Follow up of primary endpoints and stroke will also be performed by telephone contacts with the patients or first degree relatives by a nurse phone call after 7 days and 180 days. The nurses will also accumulate hospital record information on these endpoints.
A central adjudication will be performed for all reported primary endpoints for the first 180 days follow up. Every site will prepare source documents for the event and send it to UCR for central adjudication by an independent committee.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bivalirudin | Experimental | Drug: bivalirudinbivalirudin as intravenous bolus of 0,75 mg per kilogram followed by an infusion of 1,75 mg per kilogram per hour |
| heparin | Active comparator | Drug: Heparinunfractionated Heparin 5 000 IU/ml as intravenous bolus according to local practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with a diagnosis of NSTEMI as judged by the physician in accordance with current guideline definitions (positive troponin) or, patients with a diagnosis of STEMI as defined by chest pain suggestive for myocardial ischemia for at least 30 minutes before hospital admission, time from onset of symptoms of less than 24 hours, and an ECG with new ST-segment elevation in two or more contiguous leads of ≥0.2 mV in leads V2-V3 and/or ≥0.1 mV in other leads or a probable new-onset left bundle branch block.
- PCI of culprit lesion is intended (therapeutic PCI, not primarily diagnostic PCI).
- Treated with bolus dose of ticagrelor or prasugrel before start of PCI. See 2.6
- Ability to provide informed consent
- Age 18 years or older
Key exclusion criteria (10 listed)
- Previous randomization in the VALIDATE-SWEDEHEART trial.
- Known terminal disease with life expectancy less than one year.
- Patients with known ongoing bleeding
- Patients with uncontrolled hypertension in the opinion of the investigator
- Patients with known subacute bacterial endocarditis
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 |
|---|---|---|
| bivalirudinAlso: AngioxWill be administered as an intravenous bolus of 0.75 mg per kilogram, followed by an infusion of 1.75 mg per kilogram per hour). Bivalirudin will be administered alone or with a low dose of heparin up to 3000U heparin in lab or up to 5000 U given pre-hospital according to local practice. | Drug | bivalirudin |
| HeparinAlso: Heparin 5000 IU/ml i.v. ,Leo PharmaTreatment with unfractionated Heparin 5000 IU/ml i.v. ,Leo Pharma, Sweden, (the control group). Heparin in the control group is administered as an intravenous or intra-arterial bolus according to local practice. A dose of 70-100 U/kg is recommended | Drug | heparin |
Primary outcome
Death, Myocardial infarction and major bleeding event
Time frame: 180 days
16 secondary outcomes
Death, Myocardial infarction and major bleeding events in the subgroups NSTEMI and STEMI
Time frame: 180 days
Time to primary endpoints (death, myocardial infarction and major bleeding event)
Time frame: 180 days
Number of events where primary endpoints (death, myocardial infarction and major bleeding event) and stroke have been registered
Time frame: 180 days
Number of events where primary endpoints (death, myocardial infarction and major bleeding event) have been registered in heparin subgroups (U/kg, groups with certain max ACT values etc)
Time frame: 180 days
TIMI flow grade after PCI
Time frame: 180 days
Time to re-hospitalization with reinfarction
Time frame: 180 days
Time to all-cause death or re-hospitalization with myocardial infarction
Time frame: 180 days
Time to target vessel revascularization
Time frame: 180 days
Time to target lesion revascularization
Time frame: 180 days
Time to stent thrombosis
Time frame: 180 days
Time to restenosis
Time frame: 180 days
Time to re-hospitalization with heart failure
Time frame: 180 days
Heart failure and complications of PCI during index hospitalization
Time frame: 180 days
Minor bleeding during index hospitalization
Time frame: 180 days
Length of index hospital stay
Time frame: 180 days
Bail-out use of GpIIb/IIIa
Time frame: 180 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 19 May 2017.
- Derived from this study: PubMed 38575449Omerovic E, James S, Ramundal T, Frobert O, Linder R, Danielewicz M, Hamid M, Pagonis C, Henareh L, Wagner H, Stewart J, Jensen J, Lindros P, Robertsson L, Wikstrom H, Ulvenstam A, Bhiladval P, Todt T, Ioanes D, Kellerth T, Zagozdzon L, Gotberg M, Andersson J, Angeras O, Ostlund O, Held C, Koul S, Erlinge D. Bivalirudin versus heparin in ST and non-ST-segment elevation myocardial infarction-Outcomes at two years. Cardiovasc Revasc Med. 2024 Sep;66:43-50. doi: 10.1016/j.carrev.2024.03.025. Epub 2024 Mar 26.
- Derived from this study: PubMed 34903034James S, Koul S, Andersson J, Angeras O, Bhiladvala P, Calais F, Danielewicz M, Frobert O, Grimfjard P, Gotberg M, Henareh L, Ioanes D, Jensen J, Linder R, Lindroos P, Omerovic E, Panayi G, Ramunddal T, Sarno G, Ulvenstam A, Voltz S, Wagner H, Wikstrom H, Ostlund O, Erlinge D. Bivalirudin Versus Heparin Monotherapy in ST-Segment-Elevation Myocardial Infarction. Circ Cardiovasc Interv. 2021 Dec;14(12):e008969. doi: 10.1161/CIRCINTERVENTIONS.120.008969. Epub 2021 Dec 14.
- Derived from this study: PubMed 34514849Bergman S, Mohammad MA, James SK, Angeras O, Wagner H, Jensen J, Schersten F, Frobert O, Koul S, Erlinge D. Clinical Impact of Intraprocedural Stent Thrombosis During Percutaneous Coronary Intervention in Patients Treated With Potent P2Y12 inhibitors - a VALIDATE-SWEDEHEART Substudy. J Am Heart Assoc. 2021 Sep 21;10(18):e022984. doi: 10.1161/JAHA.121.022984. Epub 2021 Sep 13.
- Derived from this study: PubMed 34011198Rylance RT, Wagner P, Omerovic E, Held C, James S, Koul S, Erlinge D. Assessing the external validity of the VALIDATE-SWEDEHEART trial. Clin Trials. 2021 Aug;18(4):427-435. doi: 10.1177/17407745211012438. Epub 2021 May 20.
- Derived from this study: PubMed 33589539Jamaly S, Redfors B, Omerovic E, Carlsson L, Karason K. Prognostic significance of BMI after PCI treatment in ST-elevation myocardial infarction: a cohort study from the Swedish Coronary Angiography and Angioplasty Registry. Open Heart. 2021 Feb;8(1):e001479. doi: 10.1136/openhrt-2020-001479.
- Derived from this study: PubMed 32143733Olsson A, Ring C, Josefsson J, Eriksson A, Rylance R, Frobert O, James S, Sparv D, Erlinge D. Patient experience of the informed consent process during acute myocardial infarction: a sub-study of the VALIDATE-SWEDEHEART trial. Trials. 2020 Mar 6;21(1):246. doi: 10.1186/s13063-020-4147-0.
- Derived from this study: PubMed 31387441Wester A, Attar R, Mohammad MA, Andell P, Hofmann R, Jensen J, Szummer K, Erlinge D, Koul S. Impact of Baseline Anemia in Patients With Acute Coronary Syndromes Undergoing Percutaneous Coronary Intervention: A Prespecified Analysis From the VALIDATE-SWEDEHEART Trial. J Am Heart Assoc. 2019 Aug 20;8(16):e012741. doi: 10.1161/JAHA.119.012741. Epub 2019 Aug 7.
- Derived from this study: PubMed 28844201Erlinge D, Omerovic E, Frobert O, Linder R, Danielewicz M, Hamid M, Swahn E, Henareh L, Wagner H, Hardhammar P, Sjogren I, Stewart J, Grimfjard P, Jensen J, Aasa M, Robertsson L, Lindroos P, Haupt J, Wikstrom H, Ulvenstam A, Bhiladvala P, Lindvall B, Lundin A, Todt T, Ioanes D, Ramunddal T, Kellerth T, Zagozdzon L, Gotberg M, Andersson J, Angeras O, Ostlund O, Lagerqvist B, Held C, Wallentin L, Schersten F, Eriksson P, Koul S, James S. Bivalirudin versus Heparin Monotherapy in Myocardial Infarction. N Engl J Med. 2017 Sep 21;377(12):1132-1142. doi: 10.1056/NEJMoa1706443. Epub 2017 Aug 27.
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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.
David Erlinge principal investigator
Lund University, Lund, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing bivalirudin and Heparin in people with ST-segment Elevation Myocardial Infarction and Non ST-segment Elevation Myocardial Infarction, run by Uppsala University at 1 site in Sweden.
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 5 inclusion and 10 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 19 May 2017. 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 Sweden. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Death, Myocardial infarction and major bleeding event (time frame: 180 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 NCT02311231, which also lists 8 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 19 May 2017.