Myocardial InfarctionPhase 3NCT02182011
A Study to Investigate the Procoagulant Effect of Tenecteplase (TNK-tPA), Alteplase (Rt-PA) and Streptokinase (SK) Administered to Patients With Acute Myocardial Infarction (AMI)
A Phase 3 study testing Tenecteplase, Alteplase and Streptokinase in people with Myocardial Infarction, run by Boehringer Ingelheim.
Trial summary
Primary objective: to evaluate the procoagulant effect of TNK-tPA compared to rt-PA and streptokinase, administered to patients with AMI, by measuring the concentration of TAT at 2 hours after the start of treatment versus baseline values. 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?
- Tenecteplase, Alteplase and Streptokinase
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- No sites listed yet
- Study dates
- May 2000to Jun 2001
- 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
- Onset of symptoms of AMI within 6 hours from randomisation
- A twelve-lead electrocardiogram (ECG) showing ST-segment elevation ≥ 0.1 millivolt (mV) in two or more limb leads, or ≥ 0.2 mV in two or more contiguous precordial leads indicative of AMI, or new left bundle-branch block
- Age ≥ 18
Who cannot join
- Hypertension defined as blood pressure > 180/110 mmHg (systolic BP > 180 mmHg and/or diastolic BP > 110 mmHg) on repeated measurements during current admission prior to randomisation
- Use of abciximab (ReoPro®) within the preceding 7 days or eptifibatide (Integrilin®) or tirofiban (aggrastat®) within the past 48 hours
- Use of heparin within the preceding 12 hours
- Current therapeutic oral anticoagulation
- Major surgery, biopsy of a parenchymal organ, or significant trauma within 2 months
- Any minor head trauma and any other trauma occurring after the onset of the current myocardial infarction
Show all 16Show fewer
- Any known history of stroke or transient ischemic attack or dementia
- Any known structural damage of the central nervous system
- Ruptured aortic aneurism
- Active bleeding
- Prolonged cardiopulmonary resuscitation (> 10 minutes) in the previous two weeks
- Pregnancy or lactation, parturition within the previous 30 days. Women of childbearing potential must have a negative pregnancy test
- Any known active participation in another investigative drug study or device protocol in the past 30 days
- Previous enrolment in this study
- Any other condition that the investigator feels would place the patient at increased risk if the investigational therapy were initiated
- Inability to follow the protocol and comply with follow-up requirements
About this study
Official title: An Open-label, Randomised, Parallel-group Comparison to Investigate the Procoagulant Effect of Tenecteplase (TNK-tPA), Alteplase (Rt-PA) and Streptokinase (SK) Administered to Patients With AMI
Primary objective: to evaluate the procoagulant effect of TNK-tPA compared to rt-PA and streptokinase, administered to patients with AMI, by measuring the concentration of TAT at 2 hours after the start of treatment versus baseline values.
Secondary objective: change from baseline in concentration of TAT at 6 and 24 hours; change from baseline in concentration of D-dimers, F1+2, PAI-1, PAP at 2, 6 and 24 hours. Incidence of adverse events (AE's), in -hospital complications, major or minor bleedings and serious adverse events.
- Conditions
- Myocardial Infarction
- Being tested
- Tenecteplase, Alteplase, Streptokinase
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TenecteplaseDrug
AlteplaseDrug
StreptokinaseDrug
| Study group | Role | What they receive |
|---|---|---|
| Tenecteplase | Experimental | Single i.v. bolus followed by infusion, weight adjusted Receives: Drug: Tenecteplase |
| Alteplase | Active comparator | Single i.v. bolus followed by infusion Receives: Drug: Alteplase |
| Streptokinase | Active comparator | I.V. infusion Receives: Drug: Streptokinase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in concentration of thrombin anti-thrombin complex (TAT)
Measured: Baseline, 2 hours after start of treatment
Secondary outcomes (10)
Changes from baseline in TAT
Measured: Baseline, 6 and 24 hours after start of treatment
Changes from baseline in D-dimers
Measured: Baseline, 2, 6 and 24 hours after start of treatment
Changes from baseline in prothrombin fragments 1+2 (F1+F2)
Measured: Baseline, 2, 6 and 24 hours after start of treatment
Changes from baseline in plasminogen-activator inhibitor-1 (PAI-1)
Measured: Baseline, 2, 6 and 24 hours after start of treatment
Changes from baseline in plasmin-antiplasmin complex (PAP)
Measured: Baseline, 2, 6 and 24 hours after start of treatment
Occurrence of adverse events (AE's)
Measured: Up to 30 days
Occurrence of major bleedings
Measured: Up to 30 days
Occurrence of minor bleedings
Measured: Up to 30 days
Occurrence of serious adverse events (SAE's)
Measured: Up to 30 days
Occurrence of in-hospital complications
Measured: Start of treatment until discharge from hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startMay 2000
- Primary completionJun 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe 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
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02182011
- Sponsor's protocol ID
- 1123.5
- Status last verified
- Jul 2014
- First submitted
- 2 Jul 2014
- Last updated
- 14 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomised, Parallel-group Comparison to Investigate the Procoagulant Effect of Tenecteplase (TNK-tPA), Alteplase (Rt-PA) and Streptokinase (SK) Administered to Patients With AMI
- ClinicalTrials.gov ID
- NCT02182011
- Acronym / sponsor ID
- 1123.5
- Conditions
- Myocardial Infarction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- May 2000
- Primary completion
- Jun 2001 (actual)
- First posted
- 8 Jul 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.
Primary objective: to evaluate the procoagulant effect of TNK-tPA compared to rt-PA and streptokinase, administered to patients with AMI, by measuring the concentration of TAT at 2 hours after the start of treatment versus baseline values.
Secondary objective: change from baseline in concentration of TAT at 6 and 24 hours; change from baseline in concentration of D-dimers, F1+2, PAI-1, PAP at 2, 6 and 24 hours. Incidence of adverse events (AE's), in -hospital complications, major or minor bleedings and serious adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tenecteplase | Experimental | Drug: TenecteplaseSingle i.v. bolus followed by infusion, weight adjusted |
| Alteplase | Active comparator | Drug: AlteplaseSingle i.v. bolus followed by infusion |
| Streptokinase | Active comparator | Drug: StreptokinaseI.V. infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Onset of symptoms of AMI within 6 hours from randomisation
- A twelve-lead electrocardiogram (ECG) showing ST-segment elevation ≥ 0.1 millivolt (mV) in two or more limb leads, or ≥ 0.2 mV in two or more contiguous precordial leads indicative of AMI, or new left bundle-branch block
- Age ≥ 18
Key exclusion criteria (16 listed)
- Hypertension defined as blood pressure > 180/110 mmHg (systolic BP > 180 mmHg and/or diastolic BP > 110 mmHg) on repeated measurements during current admission prior to randomisation
- Use of abciximab (ReoPro®) within the preceding 7 days or eptifibatide (Integrilin®) or tirofiban (aggrastat®) within the past 48 hours
- Use of heparin within the preceding 12 hours
- Current therapeutic oral anticoagulation
- Major surgery, biopsy of a parenchymal organ, or significant trauma within 2 months
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 |
|---|---|---|
| Tenecteplase | Drug | Tenecteplase |
| Alteplase | Drug | Alteplase |
| Streptokinase | Drug | Streptokinase |
Primary outcome
Changes from baseline in concentration of thrombin anti-thrombin complex (TAT)
Time frame: Baseline, 2 hours after start of treatment
10 secondary outcomes
Changes from baseline in TAT
Time frame: Baseline, 6 and 24 hours after start of treatment
Changes from baseline in D-dimers
Time frame: Baseline, 2, 6 and 24 hours after start of treatment
Changes from baseline in prothrombin fragments 1+2 (F1+F2)
Time frame: Baseline, 2, 6 and 24 hours after start of treatment
Changes from baseline in plasminogen-activator inhibitor-1 (PAI-1)
Time frame: Baseline, 2, 6 and 24 hours after start of treatment
Changes from baseline in plasmin-antiplasmin complex (PAP)
Time frame: Baseline, 2, 6 and 24 hours after start of treatment
Occurrence of adverse events (AE's)
Time frame: Up to 30 days
Occurrence of major bleedings
Time frame: Up to 30 days
Occurrence of minor bleedings
Time frame: Up to 30 days
Occurrence of serious adverse events (SAE's)
Time frame: Up to 30 days
Occurrence of in-hospital complications
Time frame: Start of treatment until discharge from hospital
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 14 Jul 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tenecteplase, Alteplase and Streptokinase in people with Myocardial Infarction, run by Boehringer Ingelheim.
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 3 inclusion and 16 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 14 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Changes from baseline in concentration of thrombin anti-thrombin complex (TAT) (time frame: Baseline, 2 hours after start of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jul 2014.