Myocardial InfarctionPhase 3ASSENT 3NCT02181985
Full Dose Tenecteplase (TNK-tPA) Together With Heparin Sodium, Full Dose Tenecteplase With Enoxaparin, Half Dose Tenecteplase Together With Abciximab and Heparin Sodium in Patients With Acute Myocardial Infarction (AMI)
A Phase 3 study testing Full dose TNK-tPA, Half dose TNK-tPA and Heparin in people with Myocardial Infarction, run by Boehringer Ingelheim.
Trial summary
The objective of ASSENT 3 was to evaluate the safety and efficacy of full dose tenecteplase with heparin sodium (group A), full dose tenecteplase combined with enoxaparin (group B) and half dose tenecteplase combined with abciximab and heparin sodium (group C). 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?
- Full dose TNK-tPA, Half dose TNK-tPA and Heparin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,989 participants
- Where
- No sites listed yet
- Study dates
- May 2000to Apr 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 six hours prior to randomisation
- A twelve-lead electrocardiogram with one of the following: 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 left bundle-branch block
- Age ≥ 18
- Informed consent received
Who cannot join
- Hypertension defined as blood pressure > 180/110 mm Hg (systolic BP >180 mm Hg and/or diastolic BP >110 mm Hg) on repeated measurements during current admission prior to randomization
- Use of abciximab (ReoPro ®) or other glycoprotein-IIb/IIIa antagonists within the preceding 7 days
- Major surgery, biopsy of a parenchymal organ, or significant trauma within 2 months
- Any minor head trauma and any other trauma occurring after onset of the current myocardial infarction
- Any known history of stroke or transient ischemic attack or dementia
- Any known structural damage of the central nervous system
Show all 17Show fewer
- Prolonged cardiopulmonary resuscitation (>10 minutes) in the previous two weeks
- Current oral anticoagulation
- Standard unfractionated heparin (heparin sodium) >5000 IU or a subcutaneous dose within 6 hours of randomization of a therapeutic dose of any low molecular weight heparin
- Known thrombocytopenia (prior platelet count below 100000 cells/μl (100 x10**9/l))
- Known renal insufficiency (prior S-creatinine >2.5 mg% (>220 μmol/l) for men and >2.0 mg% (>175 μmol/l)) for women
- Pregnancy or lactation, parturition within the previous 30 days. Women of childbearing potential must have a negative pregnancy test, or use a medically accepted method of birth control
- Treatment with an investigational drug under another study protocol in the past 7 days
- Previous enrollment in this study
- Known sensitivity to TNK-tPA, tPA, abciximab, heparin or low molecular weight heparin
- Any other condition that the investigator feels would place the patient at increased risk if the investigational therapy is initiated
- Inability to follow protocol and comply with follow-up requirements
About this study
Official title: A Phase IIIb, Randomised, Open Label Trial With 3 Parallel Groups: Full Dose TNK-tPA Together With Heparin Sodium, Full Dose TNK-tPA Together With Enoxaparin, and Half Dose TNK-tPA Together With Abciximab and Heparin Sodium in Patients With Acute Myocardial Infarction: ASSENT 3 (Assessment of the Safety and Efficacy of New Thrombolytic Regimens)
The objective of ASSENT 3 was to evaluate the safety and efficacy of full dose tenecteplase with heparin sodium (group A), full dose tenecteplase combined with enoxaparin (group B) and half dose tenecteplase combined with abciximab and heparin sodium (group C).
- Conditions
- Myocardial Infarction
- Being tested
- Full dose TNK-tPA, Half dose TNK-tPA, Heparin, Enoxaparin, Abciximab
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full dose TNK-tPADrug
Half dose TNK-tPADrug
HeparinDrug
EnoxaparinDrug
AbciximabDrug
| Study group | Role | What they receive |
|---|---|---|
| TNK-tPA + heparin | Active comparator | Not described Receives: Drug: Full dose TNK-tPA; Drug: Heparin |
| TNK-tPA + enoxaparin | Experimental | Not described Receives: Drug: Full dose TNK-tPA; Drug: Enoxaparin |
| TNK-tPA + abciximab + heparin | Experimental | Not described Receives: Drug: Half dose TNK-tPA; Drug: Heparin; Drug: Abciximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoint: 30-day mortality or in-hospital reinfarction or in-hospital refractory ischemia or in-hospital intracranial hemorrhage (ICH) or in-hospital major bleedings (other than ICH)
Measured: Up to 30 days after discharge from hospital
Composite endpoints: 30-day mortality or in-hospital reinfarction or in-hospital refractory ischemia
Measured: Up to 30 days after 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 completionApr 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
- 5,989 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
- NCT02181985
- Sponsor's protocol ID
- 1123.10
- Acronym
- ASSENT 3
- 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
- A Phase IIIb, Randomised, Open Label Trial With 3 Parallel Groups: Full Dose TNK-tPA Together With Heparin Sodium, Full Dose TNK-tPA Together With Enoxaparin, and Half Dose TNK-tPA Together With Abciximab and Heparin Sodium in Patients With Acute Myocardial Infarction: ASSENT 3 (Assessment of the Safety and Efficacy of New Thrombolytic Regimens)
- ClinicalTrials.gov ID
- NCT02181985
- Acronym / sponsor ID
- ASSENT 3 / 1123.10
- Conditions
- Myocardial Infarction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,989 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- May 2000
- Primary completion
- Apr 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.
The objective of ASSENT 3 was to evaluate the safety and efficacy of full dose tenecteplase with heparin sodium (group A), full dose tenecteplase combined with enoxaparin (group B) and half dose tenecteplase combined with abciximab and heparin sodium (group C).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TNK-tPA + heparin | Active comparator | Drug: Full dose TNK-tPA, Drug: Heparin |
| TNK-tPA + enoxaparin | Experimental | Drug: Full dose TNK-tPA, Drug: Enoxaparin |
| TNK-tPA + abciximab + heparin | Experimental | Drug: Half dose TNK-tPA, Drug: Heparin, Drug: Abciximab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Onset of symptoms of AMI within six hours prior to randomisation
- A twelve-lead electrocardiogram with one of the following: 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 left bundle-branch block
- Age ≥ 18
- Informed consent received
Key exclusion criteria (17 listed)
- Hypertension defined as blood pressure > 180/110 mm Hg (systolic BP >180 mm Hg and/or diastolic BP >110 mm Hg) on repeated measurements during current admission prior to randomization
- Use of abciximab (ReoPro ®) or other glycoprotein-IIb/IIIa antagonists within the preceding 7 days
- Major surgery, biopsy of a parenchymal organ, or significant trauma within 2 months
- Any minor head trauma and any other trauma occurring after onset of the current myocardial infarction
- Any known history of stroke or transient ischemic attack or dementia
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 |
|---|---|---|
| Full dose TNK-tPA | Drug | TNK-tPA + enoxaparin, TNK-tPA + heparin |
| Half dose TNK-tPA | Drug | TNK-tPA + abciximab + heparin |
| Heparin | Drug | TNK-tPA + abciximab + heparin, TNK-tPA + heparin |
| Enoxaparin | Drug | TNK-tPA + enoxaparin |
| Abciximab | Drug | TNK-tPA + abciximab + heparin |
Primary outcome
Composite endpoint: 30-day mortality or in-hospital reinfarction or in-hospital refractory ischemia or in-hospital intracranial hemorrhage (ICH) or in-hospital major bleedings (other than ICH)
Time frame: Up to 30 days after discharge from hospital
Composite endpoints: 30-day mortality or in-hospital reinfarction or in-hospital refractory ischemia
Time frame: Up to 30 days after 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 Full dose TNK-tPA, Half dose TNK-tPA and Heparin 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 4 inclusion and 17 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?
Composite endpoint: 30-day mortality or in-hospital reinfarction or in-hospital refractory ischemia or in-hospital intracranial hemorrhage (ICH) or in-hospital major bleedings (other than ICH) (time frame: Up to 30 days after discharge from hospital). The study lists 2 primary outcomes in all. 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.