Angina PectorisPhase 3NCT00000510
Platelet-Inhibitor Drug Trial in Coronary Angioplasty
A Phase 3 study testing aspirin, dipyridamole and angioplasty, transluminal, percutaneous coronary in people with Angina Pectoris and Cardiovascular Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To determine the effectiveness of dipyridamole and aspirin in prevention of restenosis of the dilated lesion in patients who had undergone percutaneous transluminal coronary angioplasty (PTCA). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Angina Pectoris, Cardiovascular Diseases, Coronary Disease
- What is being tested?
- aspirin, dipyridamole and angioplasty, transluminal, percutaneous coronary
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 1983to Sep 1988
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Patients to age 80 with angina pectoris.
About this study
To determine the effectiveness of dipyridamole and aspirin in prevention of restenosis of the dilated lesion in patients who had undergone percutaneous transluminal coronary angioplasty (PTCA). Secondary aims were to determine the effectiveness of platelet inhibitor therapy in reducing the incidence of coronary events and the severity and incidence of angina.
Read the detailed description
BACKGROUND:
By dilating coronary stenoses, PTCA can relieve angina pectoris and improve exercise tolerance and left ventricular function. However, restenosis occurs in 20-30 percent of dilated stenoses within three to six months following PTCA making it necessary to restrict patient activities, resume antianginal medications, repeat PTCA, or perform coronary artery bypass surgery.
Balloon dilatation of the atherosclerotic lesion damages the endothelium, intima, and media of the artery. This may lead to restenosis via platelet deposition, mural thrombus formation, and intimal proliferation by mechanisms that appear similar to those causing aortocoronary vein graft (ACVG) occlusions. It had been demonstrated that dipyridamole plus aspirin therapy suppressed these mechanisms of ACVG occlusion in the animal model, prolonged a shortened platelet survival in patients with coronary artery disease, and reduced ACVG occlusions in patients both early and late after the operation. Thus, a trial of these drugs in patients undergoing PTCA was a logical and necessary step to reduce the major shortcoming of the initially successful PTCA therapy, namely the high rate of restenosis.
DESIGN NARRATIVE:
Randomized, double-blind, fixed sample. Patients were randomized to treatment with dipyridamole plus aspirin or placebo.
The study completion date listed in this record was obtained from the Query/View/Report (QVR) System.
- Conditions
- Angina Pectoris, Cardiovascular Diseases, Coronary Disease, Heart Diseases, Myocardial Ischemia
- Being tested
- aspirin, dipyridamole, angioplasty, transluminal, percutaneous coronary
- Medical subject headings
- Angina Pectoris, Cardiovascular Diseases, Coronary Disease, Heart Diseases, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aspirinDrug
dipyridamoleDrug
angioplasty, transluminal, percutaneous coronaryProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 1999 (estimated)
- Study startSep 1983
- Study completionSep 1988
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angina PectorisStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The 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
- Prevention
- Allocation
- Randomised
- Masking
- Double blind
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- James Chesebro, Mayo Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000510
- Sponsor's protocol ID
- 29
- Other IDs
- R01HL031025
- Status last verified
- Mar 2005
- First submitted
- 27 Oct 1999
- Last updated
- 26 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet-Inhibitor Drug Trial in Coronary Angioplasty
- ClinicalTrials.gov ID
- NCT00000510
- Acronym / sponsor ID
- 29
- Conditions
- Angina Pectoris, Cardiovascular Diseases, Coronary Disease, Heart Diseases, Myocardial Ischemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Sep 1983
- Study completion
- Sep 1988 (actual)
- First posted
- 28 Oct 1999 (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.
To determine the effectiveness of dipyridamole and aspirin in prevention of restenosis of the dilated lesion in patients who had undergone percutaneous transluminal coronary angioplasty (PTCA). Secondary aims were to determine the effectiveness of platelet inhibitor therapy in reducing the incidence of coronary events and the severity and incidence of angina.
Detailed description
BACKGROUND:
By dilating coronary stenoses, PTCA can relieve angina pectoris and improve exercise tolerance and left ventricular function. However, restenosis occurs in 20-30 percent of dilated stenoses within three to six months following PTCA making it necessary to restrict patient activities, resume antianginal medications, repeat PTCA, or perform coronary artery bypass surgery.
Balloon dilatation of the atherosclerotic lesion damages the endothelium, intima, and media of the artery. This may lead to restenosis via platelet deposition, mural thrombus formation, and intimal proliferation by mechanisms that appear similar to those causing aortocoronary vein graft (ACVG) occlusions. It had been demonstrated that dipyridamole plus aspirin therapy suppressed these mechanisms of ACVG occlusion in the animal model, prolonged a shortened platelet survival in patients with coronary artery disease, and reduced ACVG occlusions in patients both early and late after the operation. Thus, a trial of these drugs in patients undergoing PTCA was a logical and necessary step to reduce the major shortcoming of the initially successful PTCA therapy, namely the high rate of restenosis.
DESIGN NARRATIVE:
Randomized, double-blind, fixed sample. Patients were randomized to treatment with dipyridamole plus aspirin or placebo.
The study completion date listed in this record was obtained from the Query/View/Report (QVR) System.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| aspirin | Drug | – |
| dipyridamole | Drug | – |
| angioplasty, transluminal, percutaneous coronary | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 26 Nov 2013.
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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.
James Chesebro
Mayo Foundation
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing aspirin, dipyridamole and angioplasty, transluminal, percutaneous coronary in people with Angina Pectoris and Cardiovascular Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 26 Nov 2013. 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.
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 26 Nov 2013.