Myocardial InfarctionNCT00136929
Senior PAMI: Primary Angioplasty Versus Thrombolytic Therapy for Acute Myocardial Infarction in the Elderly
A study testing Thrombolytic therapy and Percutaneous coronary intervention (PCI) in people with Myocardial Infarction, run by PAMI Coordinating Center.
Trial summary
This is a prospective, randomized, multi-center, international trial comparing two reperfusion strategies in elderly (age >= 70 years) patients with acute myocardial infarction: primary percutaneous coronary intervention (PCI) versus intravenous thrombolytic therapy. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Thrombolytic therapy and Percutaneous coronary intervention (PCI)
- Type of treatment
- Surgery or procedure
- How many people
- 530 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Interventional
- 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 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age >= 70
- Clinical symptoms > 30 minutes
- Symptom onset <= 12 hours
- ST segment elevation >= 1 mm in 2 or more leads
Who cannot join
- Prior thrombolytics
- Cardiogenic shock
- Cerebrovascular accident (CVA)
- Prolonged cardiopulmonary resuscitation (CPR)
- Blood pressure (BP) > 180/100 mm Hg
- Active bleeding
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- International Normalized Ratio (INR) > 1.4
- Acetylsalicylic acid [aspirin] (ASA) or heparin allergy
- History of neutropenia, thrombocytopenia, hepatic dysfunction, or renal insufficiency
- Peripheral vascular disease (PVD)
About this study
Official title: A Prospective Randomized Trial of Primary Angioplasty Versus Thrombolytic Therapy for Acute Myocardial Infarction in the Elderly "Senior PAMI"
This is a prospective, randomized, multi-center, international trial comparing two reperfusion strategies in elderly (age >= 70 years) patients with acute myocardial infarction: primary percutaneous coronary intervention (PCI) versus intravenous thrombolytic therapy. Clinical endpoints will be collected in the hospital, at 1 month, 6 months, and 1 year post-randomization. The primary endpoint is 30 day death or disabling stroke. The study null hypothesis is that there will be no significant difference in death or disabling stroke at 30 days post-randomization between patients treated with PCI versus thrombolytics.
- Conditions
- Myocardial Infarction
- Being tested
- Thrombolytic therapy, Percutaneous coronary intervention (PCI)
- Keywords
- AMI, MI, Acute myocardial infarction (AMI), (MI)
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thrombolytic therapyDrug
Percutaneous coronary intervention (PCI)Procedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2005 (estimated)
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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 530 participants
Sponsor and investigators
- Lead sponsor
- PAMI Coordinating Center
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company, Guidant Corporation
- Investigators
- Felix Zijlstra, M.D., Principal investigator, Ziekenhuis de Weezenlanden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00136929
- Sponsor's protocol ID
- HIC 1999-225
- Status last verified
- Aug 2005
- First submitted
- 26 Aug 2005
- Last updated
- 13 Dec 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial of Primary Angioplasty Versus Thrombolytic Therapy for Acute Myocardial Infarction in the Elderly "Senior PAMI"
- ClinicalTrials.gov ID
- NCT00136929
- Acronym / sponsor ID
- HIC 1999-225
- Conditions
- Myocardial Infarction
- Keywords
- AMI, MI, Acute myocardial infarction (AMI), (MI)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 530 participants
- Lead sponsor
- PAMI Coordinating CenterUniversity, hospital or other
- Collaborators
- Eli Lilly and Company, Guidant Corporation
- First posted
- 29 Aug 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 is a prospective, randomized, multi-center, international trial comparing two reperfusion strategies in elderly (age >= 70 years) patients with acute myocardial infarction: primary percutaneous coronary intervention (PCI) versus intravenous thrombolytic therapy. Clinical endpoints will be collected in the hospital, at 1 month, 6 months, and 1 year post-randomization. The primary endpoint is 30 day death or disabling stroke. The study null hypothesis is that there will be no significant difference in death or disabling stroke at 30 days post-randomization between patients treated with PCI versus thrombolytics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Age >= 70
- Clinical symptoms > 30 minutes
- Symptom onset <= 12 hours
- ST segment elevation >= 1 mm in 2 or more leads
Key exclusion criteria (10 listed)
- Prior thrombolytics
- Cardiogenic shock
- Cerebrovascular accident (CVA)
- Prolonged cardiopulmonary resuscitation (CPR)
- Blood pressure (BP) > 180/100 mm Hg
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 |
|---|---|---|
| Thrombolytic therapy | Drug | – |
| Percutaneous coronary intervention (PCI) | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2005.
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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.
Felix Zijlstra, M.D. principal investigator
Ziekenhuis de Weezenlanden
Questions about this trial
What is this clinical trial studying?
A study testing Thrombolytic therapy and Percutaneous coronary intervention (PCI) in people with Myocardial Infarction, run by PAMI Coordinating Center.
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 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: status not confirmed, as of the sponsor's last update on 13 Dec 2005. 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.
Are results available for this study?
Results are not available in the source record.
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.
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 13 Dec 2005.