Clinical Expertise with Cardiovascular Drugs

… And The Disorders They Treat

IHC has had extensive experience and expertise designing, conducting and analyzing drugs used in the treatment of various cardiovascular disorders.  We have presented below some details of the studies we conducted and managed with the goal to show the complexity of these programs and through the success of these studies our competency and breadth of expertise.Examples are:

• Anticoagulants/antiplatelets – International HealthCare has managed a number of clinical programs evaluating several drugs in this category.  One large clinical program assessed patients undergoing percutaneous coronary intervention, and in patients with or at risk for heparin-induced thrombocytopenia and thrombosis syndrome (HIT/HITTS) undergoing PCI.

Further details of these studies will provide you with the scope of our experience and the breadth of our capabilities:

• One program was conducted to evaluate the ability of the drug to reduce clinical events following PCI.  IHC managed this entire program of over 6600 patients in over 200 cardiovascular centers in the US and several European and Middle East countries;
• Another very large study to determine the ability of the drug to reduce major bleeding compared to heparin + glycoprotein (GP) IIb/IIIa inhibitors, was conducted in over 13,000 patients and over 350 cardiovascular centers in the US alone.  IHC participated in the design of the protocol and monitored this successful study.
• Another study designed to assess the effect on platelet count compared to baseline and the change in renal function from baseline as measured by change in serum creatinine
• A study to assess the safety of replacing heparin with an anticoagulant in patients undergoing percutaneous peripheral (non-cardiac) interventional procedures

• Adding to the breadth of our experience and expertise we successfully completed on-time and within budget constraints an entire CABG (Coronary Artery Bypass Grafting) program. The anticoagulant program consisted of several trials evaluating several drugs including Heparin in Off-Pump/On-Pump/All Comers/HITs study arms.
  • A Phase III Study in patients with HIT/HITTS Type II Undergoing Cardiac Surgery on Cardiopulmonary Bypass (CPB)
  • Another Phase III Study in Patients with Heparin-Induced Thrombocytopenia Type II (HIT) and Heparin-Induced Thrombocytopenia Thrombosis Syndrome (HITTS) Undergoing Cardiac Surgery on Cardiopulmonary Bypass (CPB)
  • An open-label, prospective, multicenter, single-arm study using an historical reference cohort of similarly identified HIT/HITTS patients from participating institutions that underwent cardiac surgery on CPB with alternative anticoagulation regimens during the previous 12 months
  • Another significant study was conducted to evaluate an anticoagulant to heparin plus protamine in patients undergoing CABG or CABG-Valve, or Isolated Cardiac Valve surgery on CPB (cardiac surgery).  This study was designed to assess a number of important aspects of treating patients undergoing these procedures.  In this study we evaluated the test product’s capability by assessing whether the test drugs were comparable in the number of in-hospital acute procedures, such as:
    • Repeat operation for coronary revascularization or catheterization
    • The incidence and number of transfusions,
    • The incidence of hemorrhage necessitating repeat exploratory operation,
    • The incidence of other major bleeding events, defined as intracranial, intraocular, retroperitoneal, gastro-intestinal, and other major hemorrhage and other new thromboembolic events;
    • Assessment of the Bleeding Index to account for the impact of transfusion in the calculation of hemoglobin drops

Although we focused on our extensive experience with antiplatelets drugs, this knowledge and capability of working with the largest, well-known and respected research institutions in the US and throughout the world provides us with the most important attribute in a successful study – picking the right Institution, Investigator and Study Coordinator that will complete your study on-time and within budget.  We add to this capability by delivering the most experienced Project Managers and importantly well-experienced CRAs who have long-term expertise monitoring cardiovascular studies.  Whether it is a large antiplatelets study in patients undergoing a PCI or the evaluation of a vasoactive drug that reduces blood flow in the splanchnic area, and thereby lowering portal blood pressure and thereby assisting the liver in its clearance of toxins, our experience in this area is very extensive.

The ability to successfully Conduct, Manage and Complete a clinical program is, in part (a very significant part), due to the studies the CRO (IHC) has conducted, as well as, the experience and relationship the CRAs have with the leading cardiovascular centers throughout the US.  Towards this end, we have listed (~300 Cardiovascular centers) with which we have conducted studies.  Our staff and project managers have a good working relationship with these Institutions, and specifically the Investigators, Study Coordinators, IRBs and their Legal contract group.  All of these contacts play an important role assuring your clinical studies will start on time, have more complete and accurate data with fewer queries, achieve good enrollment and complete the study on time.

We also have experience facilitating the creation and management of DSMBs and CEC Committees that serve to identify potential issues before they become major problems.

It is important to note that – of all the centers in the US that conduct cardiovascular research – IHC has had direct clinical monitoring experience with those institutions that account for over 70% of all patients that participated in Cardiovascular research in the US.

IHC Experience with the following Cardiovascular Centers: