THE IMPACT OF THREE DIFFERENT GLYCOPROTEIN PLATELET RECEPTOR IIb/IIIa ANTAGONISTS ON GLYCOPROTEIN IIb/IIIa PLATELET RECEPTOR INHIBITION AND CLINICAL ENDPOINTS IN PATIENTS WITH ACUTE CORONARY SYNDROMES
- Conditions
- Assessing patients presenting with acute coronary syndromes, aiming to reduce adverse cardiac outcomes.Cardiovascular - Other cardiovascular diseases
- Registration Number
- ACTRN12607000328471
- Lead Sponsor
- A/Professor Craig Juergens
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 210
A. Patients must:1. Subjects who had their most recent episode of anginal pain within the 7 days preceding randomization. 3. Be candidates for coronary angiography and revascularisation4. Provide written informed consentB. Patients must present to the hospital with anginal symptoms suggestive of cardiac ischaemia described by either of the following clinical presentations:1. Accelerating pattern of anginal pain (episodes of angina that are more frequent, severe, longer in duration, and/or precipitated by less exertion), or2. Prolonged (³20 minutes) or recurrent (³2 episodes lasting at least 5 minutes in the last 24 hours) anginal pain at rest or with minimal effortC. The symptoms of angina MUST also be associated with at least ONE of the conditions below [1) 2) or 3)]:1. ECG evidence of myocardial ischaemia manifested by:a) Transient (<20 minutes) ST-segment elevation ³0.1 mV (0.08 seconds after the J?point) in at least two leads, orb) Persistent or transient ST-segment depression =0.05 mV (0.08 seconds after the J-point) in at least two leads, not known to be old, and not in the setting of LVH orc) Persistent or transient T-wave inversion =0.3 mV (or pseudonormalization ³0.1 mV above the isoelectric line) in at least three leads not known to be old and not in the setting of LVH.d) ST segment elevation acute coronary syndrome undergoing primary PCIOR2. Abnormal cardiac enzymes defined as:a) CK-MB fraction within 7 days and subsequent to the last episode of chest pain, greater than the upper limit of normal, orb) Total CK =2 times the upper limit of normal (if CK-MB not available), orc) Troponin level greater than the upper limit of normal.OR3. Prior diagnosis of coronary disease as evidenced by:1) A documented MI or 2) Prior documented revascularisation with PTCA, directional coronary artherectomy (DCA), stent, or CABG, or 3) Prior angiography demonstrating at least one major coronary artery with a diameter stenosis = 50%.
a. Known or suspected pregnancy.b. Thrombolytic therapy within the 48 hours prior to enrollment.c. Angina precipitated by obvious provoking factors (e.g., arrhythmia, infection, severe anemia, or hyperthyroidism).d. History or symptoms (e.g., pain radiating to the back) suggestive of aortic dissection.e. Patients with uncontrolled severe (resulting in haemodynamic instability) cardiac arrhythmias.f. Increased bleeding risk as follows: 1) Recent (<1 month) or active bleeding disorder including a history of gastrointestinal bleeding, hematuria (>10 RBC’s per high power field (hpf)), or presence of occult blood in the stool. Any patient with a known coagulopathy, platelet disorder, or history of thrombocytopenia will also be excluded. 2) Any confirmed persistent recording of systolic blood pressure exceeding 180 mm Hg and/or diastolic blood pressure exceeding 110 mm Hg at time of enrollment. 3) Any history of hemorrhagic cerebrovascular disease or active intracranial pathologic process. Any history of cerebrovascular disease (or transient ischaemic attack) within 1 year. 4) Traumatic or prolonged cardiopulmonary resuscitation within the 2 weeks prior to study enrollment. 5) Severe trauma within 3 months prior to study enrollment. 6) Major surgical procedure or any ophthalmologic surgery within 1 month prior to study enrollment. 7) Invasive procedure (or lithotripsy) within 14 days of enrollment that would significantly increase the risk of hemorrhage (such as organ biopsy). 8) Active peptic ulcer disease within the 3 months prior to study enrollment. 9) Suspected pericarditis.10) Presence of known significant retinopathy (i.e., hemorrhages, exudates, or neovascularization).g. Patients with acute pulmonary edema (rales present over more than 50% of the lung fields) or patients with severe congestive heart failure (New York Heart Association Functional Class III or IV). Patients with cardiogenic shock will also be excluded.h. Patients with hemodynamically significant valvular heart disease, hypertrophic cardiomyopathy, restrictive cardiomyopathy, or congenital heart disease.i. Patients with clinically important systemic renal, pulmonary, hepatic, endocrine (e.g., uncontrolled diabetes or uncontrolled thyroid disease), neurological, or hematological disorders. j. Patients with clinically important abnormal laboratory findings including:1. Serum creatinine >220 mmol/L.2. Hemoglobin <11 g/dL (<110 g/L) or hematocrit <34%.3. Platelet count <150,000/mm3 (<150 X 10 9/L).3. PT > 1.3 x control4. k. Treatment with abciximab within the past 96 hours.l. Patients with heparin allergy/intolerance.m. Patients currently on warfarin therapy.n. Patients with a history of cancer not known to be disease free, with the exception of basal cell carcinoma of the skin.o. Patients with any other medical condition, which, in the investigator's opinion, makes survival for the duration of the study unlikely, or would otherwise interfere with optimal participation in the study (i.e. substance abuse) or produce a significant risk to the patient.p. Inability to give informed consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the impact of differing glycoprotein IIb/IIIA inhibitors on degree of glycoprotein IIb/IIIa platelet receptor platelet inhibition during percutaneous coronary intervention (PCI). [Achievement of > 95% inhibition 10 minutes after the bolus dose is considered optimal.]
- Secondary Outcome Measures
Name Time Method Secondary; To assess impact of three different drug regimens on the combined incidence of: death, new myocardial infarction (MI), urgent target vessel revascularisation and rehospitalisation for acute coronary syndromes at 30 days.[30 days after randomisation];Tertiary: To assess the rate of bleeding and MACEs between patients given GPIs and co-administered P2Y12 (anti-platelet) agents.[30 days]