Myocardial InfarctionPhase 3ASSENT 3 PlusNCT02181998
A Trial on Efficacy and Safety of Full Dose Tenecteplase Combined With Unfractionated Heparin (UFH) or Enoxaparin in Acute Myocardial Infarction (AMI) in the Prehospital Setting
A Phase 3 study testing Full dose tenecteplase, Unfractioned heparin and Enoxaparin in people with Myocardial Infarction, run by Boehringer Ingelheim.
Trial summary
The primary objective of ASSENT 3 Plus (the same as for ASSENT 3) was to evaluate the safety and efficacy of full dose tenecteplase combined with unfractionated heparin (UFH, group A) and full dose tenecteplase combined with enoxaparin (ENOX, group B). 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 tenecteplase, Unfractioned heparin and Enoxaparin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,606 participants
- Where
- No sites listed yet
- Study dates
- Jul 2000to Aug 2002
- 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 12-lead ECG 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 (BP) > 180/110 mmHg (systolic blood pressure (SBP) 180 mmHg and/or diastolic blood pressure (DBP) > 110 mmHg) on repeated measurements during current admission prior to randomisation
- Use of abciximab (ReoPro ®) or other glycoprotein-IIb/IIIa antagonists within the preceding seven days
- Major surgery, biopsy of a parenchymal organ, or significant trauma within two months
- Any minor head trauma and any other trauma occurring after onset of the current myocardial infarction (MI)
- Any known history of stroke or transient ischaemic attack or dementia
- Any known structural damage of the central nervous system
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- Prolonged cardiopulmonary resuscitation (> 10 min) in the previous two weeks
- Current oral anticoagulation
- Standard UFH (heparin sodium) > 5000 international units (IU), or a subcutaneous (SC) therapeutic dose of any low molecular weight heparin (LMWH) within six hours of randomisation
- Known thrombocytopenia (prior platelet count below 100 000 cells/μL (100 x 10**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 had to 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 seven days
- Previous enrolment in this study
- Known sensitivity to tenecteplase, tissue plasminogen activator (tPA), abciximab, heparin or LMWH
- Any other condition that the investigator felt would place the patient at increased risk if the investigational therapy was initiated (e.g. known haemorrhagic diathesis, acute pericarditis and/or subacute bacterial endocarditis, acute pancreatitis, severe hepatic dysfunction, diabetic haemorrhagic retinopathy or other haemorrhagic ophthalmic conditions, active peptic ulceration, arterial aneurysm and known arterial/venous malformation, neoplasm with increased bleeding risk)
- Inability to follow protocol and comply with follow-up requirements
About this study
Official title: A Phase IIIb-IV, Randomised, Open Label Trial on Efficacy and Safety of 2 Parallel Groups: Full Dose Tenecteplase Combined With Unfractionated Heparin or Enoxaparin in Acute Myocardial Infarction in the Prehospital Setting (ASSENT 3 Plus) ASSENT 3 Plus Was a Satellite Study to ASSENT 3 (Main Study) ASSENT (ASsessment of the Safety and Efficacy of New Thrombolytic Regimens)
The primary objective of ASSENT 3 Plus (the same as for ASSENT 3) was to evaluate the safety and efficacy of full dose tenecteplase combined with unfractionated heparin (UFH, group A) and full dose tenecteplase combined with enoxaparin (ENOX, group B). An additional objective in ASSENT 3 Plus was to describe the different time intervals in the prehospital phase.
- Conditions
- Myocardial Infarction
- Being tested
- Full dose tenecteplase, Unfractioned heparin, Enoxaparin
- 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 tenecteplaseDrug
Unfractioned heparinDrug
EnoxaparinDrug
| Study group | Role | What they receive |
|---|---|---|
| tenecteplase + unfractioned heparin | Active comparator | Not described Receives: Drug: Full dose tenecteplase; Drug: Unfractioned heparin |
| tenecteplase + enoxaparin | Experimental | Not described Receives: Drug: Full dose tenecteplase; Drug: Enoxaparin |
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 startJul 2000
- Primary completionAug 2002
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
- 1,606 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
- NCT02181998
- Sponsor's protocol ID
- 1123.11
- Acronym
- ASSENT 3 Plus
- 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-IV, Randomised, Open Label Trial on Efficacy and Safety of 2 Parallel Groups: Full Dose Tenecteplase Combined With Unfractionated Heparin or Enoxaparin in Acute Myocardial Infarction in the Prehospital Setting (ASSENT 3 Plus) ASSENT 3 Plus Was a Satellite Study to ASSENT 3 (Main Study) ASSENT (ASsessment of the Safety and Efficacy of New Thrombolytic Regimens)
- ClinicalTrials.gov ID
- NCT02181998
- Acronym / sponsor ID
- ASSENT 3 Plus / 1123.11
- Conditions
- Myocardial Infarction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,606 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jul 2000
- Primary completion
- Aug 2002 (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 primary objective of ASSENT 3 Plus (the same as for ASSENT 3) was to evaluate the safety and efficacy of full dose tenecteplase combined with unfractionated heparin (UFH, group A) and full dose tenecteplase combined with enoxaparin (ENOX, group B). An additional objective in ASSENT 3 Plus was to describe the different time intervals in the prehospital phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tenecteplase + unfractioned heparin | Active comparator | Drug: Full dose tenecteplase, Drug: Unfractioned heparin |
| tenecteplase + enoxaparin | Experimental | Drug: Full dose tenecteplase, Drug: Enoxaparin |
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 12-lead ECG 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 (BP) > 180/110 mmHg (systolic blood pressure (SBP) 180 mmHg and/or diastolic blood pressure (DBP) > 110 mmHg) on repeated measurements during current admission prior to randomisation
- Use of abciximab (ReoPro ®) or other glycoprotein-IIb/IIIa antagonists within the preceding seven days
- Major surgery, biopsy of a parenchymal organ, or significant trauma within two months
- Any minor head trauma and any other trauma occurring after onset of the current myocardial infarction (MI)
- Any known history of stroke or transient ischaemic 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 tenecteplase | Drug | tenecteplase + enoxaparin, tenecteplase + unfractioned heparin |
| Unfractioned heparin | Drug | tenecteplase + unfractioned heparin |
| Enoxaparin | Drug | tenecteplase + enoxaparin |
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 tenecteplase, Unfractioned heparin and Enoxaparin 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.