To test the hypothesis that dipyridamole improves tolerance to ischemia-reperfusion in patients undergoing elective PCI.
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Periprocedural troponin-I release measured 8 hours after PCI.
Secondary outcome
To study the effect of pretreatment with Persantin (retard, 2dd200mg) in
patients undergoing PCI on biomarkers reflecting atherosclerotic activity
(hs-CRP, PLA2 and PTX3) before and after pretreatment with Persantin and 8
hours after PCI.
Background summary
In elective PCI (percutaneous coronary intervention) up to 40% of the patients
show an asymptomatic rise in myonecrosis marker troponin-I. This release of
troponin-I has been found to represent irreversible myocardial injury and has
been related to an increased risk of restenosis and even long-term mortality.
Persantin has been proven to induce protection against ischemia reperfusion
injury and to reduce risk of cardiovascular death or event in secondary
prevention after TIA or CVA.
Study objective
To test the hypothesis that dipyridamole improves tolerance to
ischemia-reperfusion in patients undergoing elective PCI.
Study design
Double-blind placebo controlled intervention study
Intervention
pretreatment with Persantin Retard, 2dd 200mg or placebo.
Study burden and risks
This study will be executed at the Radboud University Nijmegen Medical Centre
under close medical supervision. Treatment with Persantin or placebo is not
expected to harm the participants. We expect patients receiving Persantin will
be protected against periprocedural myocardial injury.
Participants will make one extra visit to the hospital for a venepuncture and
medication distribution. Participants are not allowed to drink caffeine
containing beverages starting 24 hours prior to PCI and until the last
bloodsampling at 8 hours after PCI.
postbus 9101
6500 HB Nijmegen
Nederland
postbus 9101
6500 HB Nijmegen
Nederland
Listed location countries
Age
Inclusion criteria
·Patients accepted for elective single, native vessel (left anterior descending, right coronary artery or ramus circumflexus (LAD, RCA or RCX)) PCI in the RUNMC or RUNMC cardiology policlinic patients undergoing diagnostic coronary angiography.
·Troponin-I < 0,20 mmol/L at screening
·Informed consent
Exclusion criteria
· unstable angina
· recent myocardial infarction (STEMI or non-STEMI), during two weeks prior to inclusion
· 3-Vessel disease as seen on coronary angiogram
· Stenotic laesion in mainstem as seen on coronary angiogram
· CABG in medical history
· asthma (recurrent episodes of dyspnea and wheezing, or usage of prescribed inhalation medication: i.e. corticosteroids or B2-agonists)
· Diabetes Mellitus type I (insuline dependent)
· Use of prescribtioned oral anticoagulants (coumarine derivates)
· Use of oral corticosteroids
· Use of sulfonylurea derivates (glibenclamide, tolbutamide, gliclazide, glimepiride)
· Chronic use of Non Steroid Anti-Inflammatory Drugs (NSAID*s)
· Administration of Repro® during PCI (complicated procedure)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2007-004620-20-NL |
| CCMO | NL18470.091.07 |